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PLAINTIFF'S EXHIBIT oe. Register / Val. 48, No. ns I Friday. November 4. nm ; KUlC, *nu DUP-2454 OCPAATMIMT or LA0* HHHHHHHHHHoeeupattonal Safety end Meatus Admmatrauoit cm rn mo k (Docxet MO. H-4JJ0I iW Occupsdorvei Expoeure to Aebeatos tuner. Occupation Safety end Health Adraituatrauea (OSHA). Labor. actiosc Cmergsncy temporary tundtrd. tvMouuir. OSHA it Issuing in ____ emergency temporiry mndird (ETS) to rtdiioo the permissiWe exposure limit (PEL! for iibiitri from 2 fiber* (longer then I sucromoton) per cubic centimeter (2 f/cc) os oa eight-beur timeweighted ivrr|*. to AS f/es. During tbo period of ih tmtrytncy itiadord. employer* may Bit all practicable control method!, inch * engineering eoatrola. wqtx preebees end partoflol protective equipment to atict the ntw limit of OlS Gber* per cubic ecatimctar (04 f/ec). Training pregrsiei irt ilao required la bo insntutM within 20 days. The batii for Util rrs ia OSHA'l determination that cootuued aatployaa axpaitn to aabottao tiadar current caoditfoas that exceed 04 f/cc petocati e grave diagar cf developing iibetto*- isdacsd cancer aad iibeeteeti ta exposed employee*. end that aa oitatgcncy etcadtrd ia ntetnary ta pcatact than. Tie ETS icrvaa alto aia prepoeai ta mile the current acbactoc itaadard punttant ta itcoee Kb) aad 6(c) of the Act. Tbit sauce tit* sequetft eamatanto on the eppropriatenett of Induding the provisions of the ETS et permanent revision* to tho aibcitei itoadord. In addition. OSHA will won publish t icptrta notice ef prspoied nilcmoking that funhtr expitias tho iuuoi under caniidirotiaa far the permanent standard lad which rouct laaw odduiar! issues logortiina tho application of cartaia provisions af the tibmtoo standard ta the construction Industry. That notice will lavtta public commenta and wifl schedule a niemaking hctnng penaant la Section Kb) a/ tha Act eaocemtng the propoted praaasnt ttvieia* to the asbestos dates At affective data far tbie m ia Novumbet . 1M. Cammaato end evidenee caoraniag tha proposed nmaiana ta the pcemaaaat standard mede by tb* US mwt bt roceived aa or before januciy 2.3664. Aa noted. OSHA will publish a notice of propoeod rulemaking thortiy that will m* dua datai for submissions ta iht asbesioo docket far the issues raioad therein. uoauui: Written coff.ntnla should be submitted o the Ooekes Officer. Docket No. K-OttC Zoom S-U1Z. U4. Deperiment tf Libor. Third Sirtei ind Constitution Aveoue. N.W. Wssbington. oc gone. fCM nATMl IWSOaMATtON contact; |im F. Foittr. Director. Office ot Information tad Coaiuasir A/Tein. OSHA. U4. Department si Labor. Room N-3137.200 Conilitwtion Avenue. NW. Wtshiagten. DC 20230. Telephone (202) UHUt. (ueaimmaaT atroaManotc Tibia of Cedents L Inoedtettoa IL Ueti Authority nd iitlpMd tit OSHA &abeetle for tke CTI ACreveOancer A Hid for it m Sufptttutf Otmimumtittr tV. OttvoetMtel KetftO Out V. Qvtau'lttve Xiik Aiilytn VL Teehneal til gcanon feasibility A. Tichatcat FeioiMity A tweiu Feiiibiiity VB. A-tvirmtiestai tapim fttgulstery niubility, ini Pt|tle<ory Anetyew VtU. Suauaary ltd Cxtiintion of tke ITS CCHibbeOiiwip.u. ijtkerity ted SigniUit. ud Pen m6 L lalroductiea Tbit ia aa eaorgeaey temporary itandard (TTS) iiiuea punuant ta Mctioa Kc) of tho Oenpodonai Softly tad Ktoith Act ef tin: (the Act) (M Stai 1IR a UJLCIU) the Construetioa Safety Act (Pub. L. flM: 40 UJ.C. 333). the Longihcroacn'e aad Harbor Worker* Cemoaaiauon Act (33 U.S.C. P4t). the Seereterv of Labor'o Order No. 1-43 (41 Fit 337161. and 2S CF* firt ltn. Thii t. -iracy ttindard eontiiti of raeiiiena tn the exuttng itandard caeoring occupational txpocurc to aibtctct. a CFK IftO.lOOl. In order to protect icpioyeei from a grave donfit fraa coaaauod oxpoouea ta etbeetot et eurreat expeeaea lavcla. OSHA hoi detrained that wotitem expaead la atbettae under expauna CMdiUoai emoting undoe tho currant itaadard fan o greva danger of developing tncurabla cancer cad ctbeitacie Further. OSHA has found tilt aa immediate nducttoa in exposure levels to 04 f/cc ae below is aicaetary ta protect luch employee* fro* duo grave danger. Therefore OS! IA it issuing this ETS te compel reduced exposures to respaad to this emergency liluitiods OSHA'l dettraiiuwso that gr*v* deafer eunently exists ii predicatod upon qumuutive ruk estioutei ta thia record which petal ta a largo number of exeats dtaths bom cinc (aad isbesteiis! among currently s\ygtd weriere which ere iitnbuttbit te continued exposures under present working conditions. OSHA esitmued the number of cancer desihs et oided through towering of the expoturt lo 04 ' f/cc. besed on C months. Lyear. 20-year. and 4S-ytr periods of txpoturts it current levela.* The predicted ec.tcer death! evoided that result from thus periods of ixpccurt an respectively 230. 42S. 372$ aad TtlA A man detailed dlieuaeion of thtec esuntetts it found m the MCtiona. Quantitative Rick Ahtiytn (Section V). Crave Danger (Sectton 111 Al and Head for ia ETS (Section ID I). Risks of this msgnitudi it permitted end actus! axpoctin ieviis dtfrned i litutsicn whieh demanded tmmediite reguiatoey action. EvchioHon of the nlvint tdtntific dsts. policy ceacidaratioai cad cxpoiun potttrni of workers hat coavinced OSHA that continued cxpoiun it the eumnt PEL sad under cetutl workpiece condmona coBs'ltutts a "grave daager* to tmployccc. and that ta ETS it neoded to protect thorn. Tho ETS regtdra that employees may not ba exposed to cancontrttiant of osbattot exceeding A3 f/ec on in 0hour thM-wcinhod avenge bciii. end permits the employer ta cheese among engineering eoatrola. week praeticto and nipiratcn to nduca expoauroe ta tha aaw PEL Hawevur. the nmnnawnt In i Wiajom(e) sc ctdixo feeribte enginttring eontrole tad tvork pnraces la' reduea expoeun iavala ia 2 f/ec mMini in effoci under this teaporxry standard. The ETS else requires employer! to laxtituie a tnimng pregrtm estthia thirty deye ef the efTtcuve date of this emergency standard. The training progem will include instruction on respirator fituag ind use. ksadlmg of cibastos. medical infcrmatien. the niatianship between smoking and lyng eaacor. and a review ef the osbesios itanderd. Tho ETS ipplitt to ell induetriee coveted by the Ac-- including "general iadumry". eoMtmcnea tad entime Industnct "Uh'QAeIHt UAmttmi enmsised.aecfvesewsawdmeln(seCnTsSeisNIet si ssIKsmwsmoseutwelclssissseores.leWctsm*seCAmTeislXstiey*stesyswsSisdiiusumsimunsrsyiatnt*isetmtspsliesm0n.*s1su1innA.siitvis eeisWM* kseefsi esnsng true so irr* msirt Wswse mk* Ins see S rtmn s( imteKn is *sm.stlsssw*l>*s<*r AslTJ Aliitsvc* ewCTg #> *rbr Iswmm Ssmujrecl wemess *m eiieitiu s* iisrlsis Use *e seMsisssd ssCmiI swsikx te issi mxv il Os ee use wwt*M Isr nesssil nsr>s>>n is OClU > tisswsi Ml Nlaam usstiu me Wm swsHsay Svmsim IM sssisu<-<( eiwMtiw (Sr t iswesssw luaesw vioui 4 MM*s ef sa cn Im we sss W sees OOP 0907159 iJu ry5 DU 028260 A provided m a OH mjJU. ih* j* Skim wuh their own OSlfA-apornted eeupttiontl safety end health pUnt art expected to adopt cetnpareblt itandard within JO dayt af this publication data. TVm Slataa art: AJaaba. Ahaona. Citfonia. Connecticut (for Suit and iocal javtmmtnt ' employee* oaiyj. Hawaii. Indiana. Iowa. Xinlucky. Maryland. Michigan. Minnesota. Nevada. Now Monica North Carolina Ortyen. Puerto Rica. South Carolina. Tinneiie*. Utah. Vennoni. Virginia. Vlr|tn lalandi. Washington, and Wyoming. Aiaa in raeponae 10 the emerjtncy eonditiona faced by aapoaad workers. OSHA la itappini up ita enforcement activitiei in targeting workpiece* where aabeatoa i* handled. Tie temporary provisions that ere being added to the enictini aabeatoa atandard preaenbee the major components at an occupational eafaty and laalth standard. In |aral. meat of tho current nquiramants remain unaffected by the emergency temporary atandard. However, compliance with . pome requirement* will be triggered by the new exposurt Hatit of 0.S f/ee ... btateed el the former PCL of 2 f/ee. For example, rcquiramtnt* such a* ebang* * .room rtmam uneffacted by tho ITS '. and tho trtqgsr level for change room remain! the former PEL of 2 f/ee . (| ina.IOOlldXdl). However, the CTS rvquim that where concentrebons may txcaed the new PEL the employer mutt post itgni indieatlni tech locations (I inmanikXS)). OSHA bated tta daesioiu eonetnin appropruia prsvitlana for the CTS oo tta diiarminatione of tha kind and degree of protective aetioii aeedtd to prated a|oinst a ^.ro dan|tr and the fallibility if insututing the** proviaion* during th pined af tha CTS. Under socuea Sib) of tho Act. OSHA wtU ahortty schodula an informal rulemsking hearing on the prepoeed permanent chsn|et to tho atandard. OSHA will also propose other revisions to the aabeatoa standard that will be explained the ttparste netiee of ptopoatd rvlamohin*. Appiiaatioo of eorum proviaioM of tho asboatee aundard to tha oonatmtton Maury will be tetaed at that time. OSHA anttepatei that tfcsrnodce end bn pebdehed shortly. OSHA is now accepting written somennu an thoao (taaea reiaod hi tbo SIS whkh are ruJcvan* te wviomg (he permanent nda. The Seewsary morn promulgate a taction Hli| standard nn Lief than me month* after potrticanon of tha mrrgrncy atandard. It legal Aatbority and Packpouad A. tjwt AuiAeruy Section c| of the A*l provide for immedlotoly alTaetive smergvney temporary atandarda in eartain etreumstane**. Tha Secretary hta the authority tu iiaut luch a itHndard. without rulemaking. "if be dcitrmma* (A) that employees art exposed to trove dancer from exposure to substances or stent* dstormintd to be toxic or pnysteoily harmful or from new harards. end (S) that such ameryancy atandard in swnuiy to prottet amployoes from sueh danger." 29 U.S C. UKeXH Thus, tho dangar must bo "trow* worfcir exposer* tad it must be "gravt." net merely siynlficoat and the reyulotion meat be "naeasaary" to eddresa "such dangar.* not merely msonsbly neecssary er appropriate ta provide ssfo tmploymant. In addition, at in atetieo C(b| permanent atandarda OSHA may Impose raquiramtnta in die amsryeney itoadard only to tha txtent that they are feaaible" within tho maoniny of aoctwo tfbMSI of tho Act. The Fifth Circuit.bat amphaiisod tho importaneo of tho *everity of health affects m OSHA'i ooruideration af whether ao ETS n appropriate. ** * * thadnyrafincsrikla. pamanant w fatal conaaeuancaa ta wetkan. at eppesed to aaaily auraWa tad Ibesay t/faeta an thaw health, become* important la tha amuidaratiaa of tho sactnaty far amarymey aaaurv* ta moat a gnaw daaprr." /Tonal* Aeoch Crowem Arnttittwi tin. v. Uiutd Suit* DtHrunent of iohar. an FJd. ta (CASV . OSHA also has Interpreted relevant fediciei daemons ta rveeira that ita evaluation of tho privity of tha danger and the nccesuty for tmetyency action matt bo made in i context ef actual werkplace conditions. M. Saekjmund' t. *tnrt Uodint u tha TS. In lune. 1992. OSHA reeeived t petition far en CTS bom tho International Allocation of Miehmiet* and Aaraopoca Werkort CExi. 9^2*4). Subaeeeemly lettam spooning this potman were reserved from 19 ether unions (Ex. 94-29t te **- . 2*4.9*41? to 94391|. The petitioa ranue*tad an CTS tc reduce the PEL te 0.1 f/cc to modify mat txtstmy work prtetico requirements, sad to reqeiro other protactive provtaiona regard#** of exposure level. The stain reiaont sat forth ia the petition sad iippontny letters are diet continued exposure under current workplace condition! constitutes a yrave danqor and that delaying remedial action until s permanent standard t* promutqntad would coat tarye numbers af eunemiy* evpoKd workur* lhetr llv**. OSHA sheet* the penuine eoneam axprroco by the petition end tetter* from unem rtpreientmy thouiandt of tmplo)ee* who art directly fired with tho thre.n of brttot-reieted ditcitt from continue2 exposure. And OSHA conclude* that failur* to i**u* du* CTS may eon a number of exposed worktrs their live*. In Aefiut IMS. OSHA eemptated a comprehensive nsk itiMsment bused on numerous human, studies which ettimtiid the number of txeots death* from the three tutor (tbtstsi-rtiaiad eanetr*. to., tuny cancer, mtsothuliuma and (ittrointetiinul cancer. t the current perrannble exposure lard of 2 f/ee end st various reduced txpoaur* lavaia. OSHA placed thia document. 'Quantitative Risk AaaMiment for AtbestetdLlatad Canean". ia tha Aabeatoa docket m Auyutt 1993 (Ex. u> M9J. OSHA subsequently revtiad thu document (See Cx. 94-3921. L Hiitory of tha Atbtttot Standard. OSHA hai rtyulattd aibtttoa ainca 1971. A 12 f/ee limit for aabeatoa wet included in the initial promuiyatlon of OSHA standard! pursuant to lection l(i) of tha Act an May 2*. 1971 (5SFR 10tG4). In rtapooaa to a pontion by tha Industrial Union Department af the AFL-GO. OSHA issued ea CTS on asbestos on December t. 19H. which sittblished s PEL of I f/ce ea s timeweighted avtrayo baits end peak exposutm af 10 f/ec. Tht eutraat uandard. promulgated ia lune 1972. first ssubliihid sn S-hour bmo-weightad avaraye PEL of S f/ee and a ctUlny limit of 10 f/ec. The limits wt*t intended primarily to protect amplcvtes ayaiaat aahoatasii. and it wn hopey that thay would provide some tnddtauJ dayrte ef protection eyatnat eaneer. Efiactivo July 1129. the TWA limit reduced by the siandurd to 2 f/ee. Tha limit haa remained in affact tinea that Urns. The standard also includes prevision* covering methods af compliance, menitenr.*. medical turveillanea and houtaktaping: Court reviaw of this ttnndard upheiii ail maier provisiuna. but remendert nn issue* for OSIIA's reeonaidaraticn. I'JZ v. Hodftcn. * P. 2d *97 (CADC uni Those issues wet* whether the July 1?*S date for the 2 f/cc stunderd should be sccoltrated for some Industrie* and ir: adequacy ef the 2 year rettntion penoJ far expoiure monitoring records. Subsequently. OSHA mcrvnsad this retention period to 20 years (41 FR 11J04) and the accelcruuon issue became moot. After reehewiny the then iiv.-til.thli' riennfic data, ia October isrs OSi I \ pubiiahed t none* of proposed JOSf?6 DUP 0907160 DU 028261 s^oaa f'*d*f3| Ki-vmgf / Vqi. j(j' ,0 i pndjv, Navtmi'tr 4. iygj l KuiM 4AQ *r$w4.iuoi rulemaking to revue the sibetto* standard because OSHA believed (hat "sufficient medie-l end scicntd* ' ttiiicnct had been accumulated to warrant iht designation of tsbosios k a human carcinogen" ind t)ui ads itui In monitoring tad prot.ttv* technology mid* reexamination er.ht standard "desirable." This prepoeai would have reduced the Uat-woighttd s veragt to 04 f/ee ind imposed 1 etilini limit ef 5 f/ee for IS mlnuirs (40 FX 47U2). Th* boil* for thrll'J proposer* roducod permissible lovol 0/04 f/ee woe OSHA's then current poliey let earaoo|u that no safe threshold lovol wo* demonstrable end. ihortforo. tbo Act required 05HA to tot the KL at low at icchnologiuUy tad economically mud* by the ETS end the sdditirmai proposed emendmenti rutted in the noner of proposed rulemaking to be pt \ilished toon The nuior tubicctt of the C(hl njlmrwkirtg ill br reductnf the permiiiibie evpoturt ItauL rtvitmg the defirutiunt of etbottet tad ttbettot nbcri. reassessing tho methods of compliance to achieve cuch limit*, revttmg the provitient regarding retpintcr ifitction. rovtiina the templing ind tntiylicai method to improve reiiebthty. md adding training requirement. OSHA will elto rune muee regarding the ppiicttton of the permanent standard ta Um eanttruetiot industry. Aa provtoutiy stated. CSHA will toon publish t separate notire of proposed ruiemeking 4(>c*te-r*leltd divest* to the current Ilbcttot-expoied working popiiauun. comparing there risks to em*r oceupaiiotui ritkt. applying relevant policy consideration*. end rtvtewmt ii rtifvcnt lodtcttl decisions for guidance the egeney bet determined that bmn prongs of tha statutory test are mat and that an ETS tbaeid be promulgated. For purpnre of tlanty. the discussion is divided iata twe parte. *Crevc Dinger" end -The Need for in ETS' OSHA beitevtt. bowtrer. that the feetcre which indicate that 1 sublime* constitutes t grtvt dinger are related to md overiep there which determine met ta ETS is necessary. A. Chore Confer feasible. This policy wot (ojoetod by tbo ta further ctploia there issues. OSHA hat dtitrmined that tht ntk to Suprtmo Court in the bonaono docitioa [!UD vs. Aft. 441 VS. HI (1M0|). OSHA IU. OSHA't Rationale far tire ETS lifliitod tho proposed rvvitiont ta tbo ~ OSHA hat determintd that prevailing lin noOeo to til ladattiiet except conditions involving worker exposure to construction. No hearing wot scheduled tirboret ttbettot dust justify tbo on the 1*75 proposal. Also. tlthoufb premulgtnoo of an emergency OSHA snnounred its intentioe to temporary tttndtrd. OSHA atttmatoo develop t ttparato prepettd revttioe that tpprosimtttly 575.000 worion ore applicable to the eensmctfea industry, exposed to ttbottot it vaheut lovoit no tueh prepotai hat boon pobiithcd ta (Table t). ringing from t high valuo of date. 20 f/cc to below 0-S f/ui OSHA hat OSHA it bofin* ilt prevent dectien ta ettimattd that under current exposure litue an ETS. ind ta propoto revisions cunditiuns asbestos-exposed worker* to tbo permanent standardTovtmtg all ftes in extraordinarily high rick of tatpievoat.' oe information and analytaa coatnctieg ubeila*-related catur which pootdato tbo l*v* proposal whether tho nek it eompstad ever 0 Thartfora. tbit ETS marks a acw working lifetime of expoaure or for regulatory lnttiatrva. reiatod to. but not expoiure penodt at ebon >10 month1. pan of the t*7S proceeding. Oo May it The average excess cancer nsks for oil 1IU. OSHA eontulttd tho Centtrection workers txpoird above 9 5 f/cc using - Advitorv Commmto for Occupational tvttlxble exposure data ind relyteg on . Safety end Health (CACOSK) the nek tttetament art estimated aa concerning ippltcebil-iy of t r.ew approximately Its exeats cancer dtotht etbettet nandard for the eotumietion per 1000 worken for S yean of iaduttry. CA( OSH tnOorsed OSHA's expoaure. 12* de a tha r 100C workers petition that chan|ta m the TO. mid* for 20 ysan. 10 por 5000 worken foe 1 ter gtatril induttry ihouid tlte apply to yett. and t per 1000 workere for the centiruetioa induttry. OCHA it alia months ef exposutd. including <ha eommentt and dtta received ta retponto to the tor* aotica OSHA beitevtt that ntkt of three magrutudet. taking into account all in the record at thit proceeding. with tbo relevant esnstderetiont auch aa total underttaadini that tome cefluneaten numben af workers at ntk and quality workers from exposures te itbtitot tt conditions that exist in the workplace pore * grave danger of death from concor and of snort disability from the lung disease, ssbtitesis. la making a 'grave denger' determination. the seventy of the dlreess produced by cxpocure to tho regulcted subetenet end tho megnitudo of the predicted ruks of dtsoecc must bo considered, in addition, tho Supremo Court has suggested that a determination of 'pave danger* indicates 1 situation whin the risk is man thaa 'ligatficaar [MD v. APL tuorta.4k OSHA hat applied that analytic approach endorsed by the Supremo Court for 'significant ntk' determinations in evaluating tht gravity of th* dangtr faced by ssbcstoi-cxpoitd workers. The Supreme Court gave some general guidance si te the process to bt followed. It recognised that while th* Agtney mutt supp'- ts rinding thst e eertein level of ritk exists with substantial cvio'tnet ft also recognised that its dattmmstian thst 1 particular level af risk ie 'significant' will bo based largely on policy esnstdtrettun* UVD v. AM. 440 U-5. US. ISO. n. 02). OSHA bebovoa. Iharifori. that its miy have changed their poottioat bated of supporting data, cansituito to datamunauana rrgsnbn; the magnitude on intervening tctoaufic developments emergency situation which requirei ef the risk fared by cmpicytet should, and potto- thiita. la the decitten to ittea oa CVS. (ho Immedict* retpome by (he tgonev. Tie Act stein that when cartota ts th* aatent pouible. rely on qusntttaliv* expretetons af that nsk. Agency bee reviewed thia regulatory statutory criteria ore met OSHA it `Vbliting tho bast avctlabie in* htttory of asbestos. However, tbo ttttkohwd to respond to on emergency The Court stated thst tht ngnirieant Atmcy bate* the deeiiien ta ent aa tituelicit by issuing in ETS. The two, nsk deitntiinsuoo requtrtd by tht OSH ETS on tbo actual emoryency tonditioni pronged statutory test fur on ETS it that Act tt ~no * mathematical straitiaelri." which aow confreat exposed workers, (11 tmployore mutt ha oxpneod ta a and 'OSHA is not required to support an epidenttalup* nedict that prevtdo grate danger from exposure ta (tt finding that a stgntficim nsk exists data ta Mia oowertcal ettireoiee of tulittuncat or agtmc determined to bt with anything pereaehmg scientific rtxkc aid oa iasorpreioiiong of thoco toxic or pnytieiell) harmful ana that (2) certainty. *"A reviewing court |ii| to ttudtot uxina qwafuiuti** nth enuiytts. on emergency standard ie neeetiory to gtvt OSHA same leowey where its I. The Kuldtaiinf u> Item* lie protect employee* from tueh dettrert. fidmg* nut be made on the [ronurm /Vrmutu'itr S/am/ord The Ofbl After evaluating eli the evidcnca of scienufia knowledge |nd thutl rulemaking initialed by tbit prepotai ta evtiililiio to the agency concerning tbo th* Agency it (re* la are conservative intended iu be limited ta the revniana seventy and magnitude of the ntk of taaumptions in interpreting die d.<tu 1 f b. f rn JUvO// DUP 0907161 DU 028262 fdr3l_gfti*t / VqI, g 3i5 / Fridsy Mpuembcr i. 133 / Rule* nd Regulations s: om with rcspret Is csrunotens. risking mar an the tide of overprolection rather ihtn underproteetiun* [it* US si ID, |K|, In the en* ot asbestos. tha data sviiltbit trt of unutui bneilth and high quality. Howtvtl because risk tutsimtm ittalf involves stay uncertainties. OSHA ftitde certain assumptions is tu analysis tad evtlutusa of thtt* data, la tiiMtlai tha risk far ttbattM-txpettd werksrc OSHA bat ttttmpttd ta tit raaJiaue assumptions. although tha eaufl ttatad that tha Agency wat fraa ta tua "esnisrvttivs assumptions" in Intsrpreting data. OSHA. ia many eatos. haa ladieatad where diffartat ttmmptioni may product diffarant results. la addition OSHA eautions that bacauaa the nth figure* finally derived art the produot ot a proctat which, aa the Supreme Court acknowledged. ft "on the frontiers of idenee." they thould be viewed aa approximations of the dagtsa of riak faced by ssbettot-exposad workers aad sot at preeaa fixed predicticnt of the auatber ef workara whs will actually develop ditaaae. OSHA hat evaluated the kinda of dangeri prtiented by atbettot -- expoture. the eutntif!cation of those dengsrs under praaent asbestos * sxpo*urn-condition*. the duality ef tha ' data on which risk tttinttea an bated, a tMtpcriiea ef atbeatoa riika te ethee occupational riika. aad relevant policy and legit cantidcratioai in concluding that workara are expoted to a grave danger from asbestos. 1. Natan of t/ia Distant. Aa stated above, the nature of the diseoso attecuted with exposure to t toxic lubatanet It - ne of ' moat important eltmenu OSHA veluatet la determining whether a grove danger exittc This fector was discussed in Florida Peach Grexran Attatiuian. toe. r Uaitad Stem Dapenmaat ofLake*, tupre. Tha eotm. is overruling OSHA'i orgonophoiphota pesticide ETS. abterved: We reject toy umuiitt that deethe ewat eeeor brier* h*iik end Mitiy naudaiue auy be sdnpicU. NcvtrUwless. (*edererf wcwekfr. pwnaswc trfatai aantaoHmeaa at wa/iert at eppattdm tatUy outdo aad fltttiat rifte/t ta Umtr OeekA heeemot maanaat ia tha aaaaUtmfiaa atthe mrattay far tmtnartr --ursrrs m man a gieve dengen tea r M US (eamkaew edMI OSHA ia aware af aa instances Is which expacara ta a lex* tahtunce haa more clearly dastanatfated datrisitatsl health effect! on human* than haa aibeitoa axpoeure. The daraiaa canard by aibeatua tvpoeuni .re m largn pan Ufa-threatening or disabling. Among then disrates ere lung c.inr.r. cancer of Irveta which workers currently lues. the meiotheiiet lining of iho pleura and Meat ef ihe results af these uieulutioni peritoneum, and ailicttsiia. In addition, for cancer art presented in Table u m worken upoied to iibeitoi ire at the nek tisaaament muon of this Ineresitd ntk of gaatroiniesunai oncer, document. t ihown by epidemiologic atudiet. The table seta forth predicitd e.xet'ts Allhough eoltf-reetol eaneir may ba lifttimo canear risks let exposures of eurabla if detaciad In an tarty ttoge. one year. 20 years tad a years. Risks other gasuoiotcaimal canesn art for exposures af months sre elossiy usually fatal. OSHA alto btliovu thtt ipproximated by ono-half the nsks for ubeitet might induct cancan at other sxposu/ss of ana yaar. Although avarag: Itti. which art olio oftan fauL exposures ia demolition and renovation Of thru, lung cancer constitute! tha greattii haaith rich for American an estimated at JO Vet. tha table presents risks anly lee salactad sxposun tibtitoa werktra and hat accounted for levels up la 10 f/ee. awn thaa half af exeats mortality Is omt occupational coborta. About Kh of lung cancir patlanu dit within S ytsrs ef diagnosis. Maaothaiiooa it aa Thaaa calculsttene show that tha rtsls af tsbettaa-raiatad disease an slaraimgiy high at eurrtnt occupational exposure levels. Foe example, to incurabl* canctr which ia uaaaliy fatal estimated tout canear ntk of 28S excess within a year afttr diagnosis. U ia death* per tOOO workers txitts for epidemiologicaUy Unked ta aabettoo expoiura. rad oceun vary rarely, if at worken expoted tee a 4S-ytar lifetime at 10 f/cc a love! which currently exists all is persona never expottd la tibestei. Atbusioti*. a type af pulmonary fibrosis. la oauaily non- oa torn* construction sites. At I f/cc. the expoeure levels which an ccastdtnii sverse* ta shipbuilding and repair, the reventblr. its advaneod stages art disabling. aad can bo fatal. OSHA concludes that all thaaa dliaaies art vary ssnaua. and that tha txettt mortality bum ouch levers disaasaa muet.be considered in important factor for making t grave danger deUrmiMtiae. t Dapeat afHitk afDavaJoping . Dongtnoa Cistesi. OSHA baud Its calculations of axtost ef risk faced by worker! under current expoiura condition! primarily on the reiultt of a quantitative analysis whieh dirivtd numerical estimates ef cancor nik at * ' various cumulative exposures corresponding to levels at which workers ire exposed "t*. 14.332). Although 2 f/ce t* tha eurrtnt PEL for aabestoa expoiura. actual exposure conditions vary widaiy. mostly by industry lermtnt Aa explained Uter in this document end as set forth in Tablo 1. avarag* aabitnt expoiura levels in various industries include high enposuxa Uvalaaarit it 201/ec in drywtli remove!. rtnavatian and demolition: I f/ec in thipbuilding and repair, mid risk el dtvoloping asbtstoe-reiated canear for a s*-year expesun period it ldf nasi das the per 1000 workara. At the current permissible level of 2 f/ee which also rtptottatt aeteal txpoturo leveis us such industries si secondary fabricating af cement shsat packing gaskaia and papar products and rebuilding and ntselng brake*, riak It tttteattd as M txcat* canear dtaths per 1000 werkart far a iHfttr axposur* period. - These risk* remain very high when the period of expoeure for which calculations are done it aherttntd to 20 yean, which OSHA behaves is another appropriate peint for nimmsoan. The period of 20 yttn t the approximate midpoint between I year tad 45 years ef xpoturt: also many workers netivt 20 ygars of exposure. Counterpart risk calculation* ueiag c 20-year expoture penod arc for workin exposed te 10 V cc. 140 txetaa canctr deaths per 1000 svorkerr. for expoture* to 1 f/ce. 105 excess canear dtaths pa: 1000 workers end for exposures to 2 f/ee. as txettt range exposure levels such aa 2 flee in cancer deaths per toon worken. secondary falinesung of cement sheet, . OSHA alto tstimsttd nsks of pocking and gasket! and poprr products developing cancer for a one year period and rebuilding and refacing brakes: 14 I/m far dry practising ef textiles: and of txpotute at various levels ta which tmployces are expettd. Thu counterp.irt lower expaiura level! such as 04 flee risks for sxposurts to 10 f/ee for one and 04 f/ee In the manufacture af floor yaar arc IS excess cancer deaths per tile. 1000 workers: to 1 f/cc 1 excess eanerr Secsuse OSHA It required to consider dtaths per 1U0O worksn and to 2 f/cc 3 the actual danger faced by workers m exeess canctr deaths per 1000 worken assessing whether expoiura to a Even at current workplace exposure abstanct peasants t `pave dancer". levels which ere less thun the current OSHA looked at the risk of developing PEL extroorilinaniy high nsks of . diaaast not only at tha 2 f/ee dieoete exist. At 05 f/ec 17 excess pnmintrie level bat at alt expoiura cancer deaths par 1000 worken trt .1 J w . r-. o DUP 0907162 DU 028263 Hi ip*-* s-*>doMMlfci a^ iiiSaiaai,iiihry-^ifftaia' 51090 r,a,M.l|.l(i!'>l*f 1 val <5. No. 21J / r-iu.iv. ,Hw<.ii<w<.i - , ^Ull . predicted (or * as.year lifeim* e*p*ur*. and 1! ixctaa caacur deaths per 1000 workon (or t yt*r tapoaurt period OSHA asm that the above calculation! are for canyr nsk only. In addition. sibeatoirixpolrd warkan face a hi|h nak of dtrciepm/atbcatuaia. a d.tabling and often ioUTdiaeau. Pradieuoai concaniit| the eattmaiotl sia|rutude of the aabcaioaia nak have beta performed by OSHA and are discussed ta the nak aaatiwneat aecrion of thia document Accordin(ly. OSHA ruinated that at 2 f/ce. 50 H-eriaro per 1000 axpoaad to aabeatoa for tS yaon will develop disabling aabtatoaia. At 04 f/ce for 45 year*, it ta ootimatcd that 12 worker* par 1C00 w J1 develop diaablmi asbestos*. Aaboatoaia (taka can olio be tobmatad (sMxpoauns for duretJoot ahortar than 45 year*. For oxamplt. the rtak of ditablini stbaatatts from xpoaurt to 1.0 f/ec for 224 yeara is 12 ceaaa per 1000 worker*. OSIZA'a taUmatea of the etaputude of the ubcateaia nak art baaed on round data from good epidemiological rtuiia*. OSKA beiltvtt. however, that the confidence which can be placed in ' predtetiona of aabtatoaia risk It not oo freataa for tha predictions of censor rtak. Thia (ibecouco the eatlcer rtak eottmatat an baaad aa a larter and * ore verlod data bate and art derived from doae-exirapeUttea modola that an batter eeubliahad lacauae OSHA hot ditaRciaad that tha riaka for cancer atone iadlcate a |nve danyer. the additional riaka el dovolontng ubtttoaia arc net aeeeeaery te fuaii/y thia ETJ. However. OSHA baa eanaidtrtd that tha additional and independent nak at davtloping ssbastem "cniiei tha dangor faced by eapoaod worker* and underscore* the gravity at tho koolth throat* is aaplcytu poaod by aabtttoa. 2. Quality of Data on Which Bilk Estunaitt an Bond. The underlying data apt* which tho gutnUlnlivt rtak eaecteeioni* for aabaiie* an band an high anility tpidcniolaftc atudiax. conducted in occupational envtimnmar.ta. OSHA emphaalxoa that tha data bare* fat aabene* an at unuautl ouabty and itm. Unlike amt potential oceupedensl earemofen*. eabeitot hue been atedied eften and thoroughly tat evaluation at tie effects on occupational population*. la deriving Skew gaoatitatfvo estimate* ler eaneer nak. OSHA atilitad eleven atodwe tar the celceleUen at the lunt caacer nak. bar of which wen alto used to calculate .he m*othWionss nak. Investigation* involved "cohOit" ptodita where the (rreuanew* at various type* at cancer* in werkar* aapend to l*io* war* compared to thaw in 'enntroi" group* not exponed to baeard. where the data am csnaidcrud hoth available *nd reliable. hieiio* or to than of lonoral The rtak of exceia mortality ett.mntru population* tueh at UJ- (isle*. Studies aa a moil atetpexurt io iibatim <i the of tueh dc*i|n ire able to provide direct conditions in the workplace today ttimetet at tteeti nak. appeal to be aub*iinitalfy higher that* The ttudiet and by OSHA in <terivin| other nak* tipenanced by worker* from dote-reaponae rtlutianahipt for tta nak occupation*! injury hatarda. The tatttament covered a variety of work Naboiwl Safety Couetil (NSC) kit ittuationt and Induttrul proceattt. This rvperttd the omutel death roiet m 19*1 vanety improve* the predictive value at from werk tcedenli in vanety of the rtak aaaeatment beceuae it Imiiiu laduatre* (Ex. M-539). Uim* the NSC or iliminotot (ho peaaibility that tits dote OSHA has reviewed the ennutl malts wan unigut ta any on* Banality from work aeeidntii per tooo occupational aituation or won in feet workon in aevertl induatnet in light ol aberrational. Tho occupational tetunt* tho oxen* cancer moniiny from a atudlod wore: worktr* txpoaed at t aingie year of expotur* to aabetioa par chryMtil* toxitlt plant from ttXMlTO 1000 worker*. For example, tn the high (Bomont it tL tax. M-OM end M-OJT): risk occupauona at ajnculture end Canadian worktn at on Mbootso miainf-*varTytit|. the tmtuei mortality eamam facility (Fiskeltttio Ex. M-200): rtits freai work aecidtnit were 0 54 4nd Italian ehryaetil* miner* and miliar* 041 per *000 worktn retpcetivtly in who worked during IRb-lNS (Rubin* un ftk. M-33P). ta csmrui. the ditth at at Ex. M-tdk workon in an aiboete* . nte from work teddenta for ail eameni pip* plant fWeilJ el ol. Ex. tt- Industrie* combiaad was 0.12 per 1000 20dk workon in in tiboitet prodsetton worker* in lit*. plant and iibcatoi coatompipo focisry OSHA bio tttlaieled that the lifetime (Henderson sad Cntorim* Ex. M-4*); risk far one year at expoturo te 2 f.'ec of Brttiah workon menufuctwriiig saboatoo labeate* ta abeut 5 axcaei eatear death* textile products (Pot* Ex. M-Udp oabtftv* minon and miller* in Quebec. par 1000 expoed werkan durinf the rememder ef the workers' lifetimes (Ex. Canadd fliddcU el ef. Ex. H-ll); and in ' 4-540). Thu*, tibrstoa workon' risk of tho Theiford Minot. Canada (Nickoiade ' exeat* cancer mortality from i nn|l# alalia. 14-72): sad workon year ef exposur* ta 2 ties la raushly S mnnufeeturing aibeait* friction * * bmae higbar than iha risk ef acsdmtaJ mattnal* (lorry and h'twhoua* Ex. 54- occupational fttalitin from ana year at 2U "W*U-eonduet*d epidemiologic ampfoymant In agrieidtuto and atiningtuarrying. fludlet that absw s positive ostocitllon' Aa ahowa in Table l OSHA Htimate* betwooa on i|*nt and t diaaoao are . - that many worktn an exposed to eccepted the eteat eenvinctni eibettoe la the viemity at 2 ffes. In evidence about human rtak" (Kick addition. OSHA calculated tha inia|i Aaaetament ia the Federal Government exerst cancer risk to worktn exposed Maaaimo the Procees. National at condition* that exist la the workplace ((March Council 1A p. 21. Ex. *4- taday (for that* above 04 w ee and usmt M2)- . tha leanaria daienbed in Table 5). Ne extrapolation '-jia aaiaal data to OSHA aitlmatas that 10 lacoat cancer human datn ia nacaieery in order to death* w ill occur par 1000 workers for 1 ahew earxinogeaioiy at asbetto*. Far moat aubittnca*. OSHA suit infer year txpoauru: thus the avtratt nak to worktn (txpoaed above 04 f/ce) in tha hamaa health offset*, inch os csrnnostnicity, Ire* animal dots. Tho results of this nak atacaamanl performed by OSHA *srt* well with enter rtca.it nak ataeatmenu performed workplace today ta approximataly 20 Halt* tha annual fatal accident rata* m fnculturt and mming^uarrying. The** campanaani are ttnkir.; They how that tha ettifliatld risk of dying of by other governmental and eutatde aewnttau (toe Acheron and Gardner) (Ex. Bfegic end 0*-:OI: EFA (Ex. 04UOk Kang end Che (Ex. P4-C01); Selileff I ai (04-003): and CHAP (Ex. 00-250). 0. Ctmparonvi Analysis. Insight turn tha magnitude of tho nak aatom*tad with aabeats* expoauni eon be gained by reviewing other occupational naka. OSJiA believe* :t it inatructiv* ta compare atbeato* naka with ether workplace hazard* terttd oat a* pmcntutf an unuatMUy high dr*r*a at eancar from aabeatoa expotur* " cxiiting tt the worksleea today f*r exceed* tho accidental death tatt tn tha riskiest of uiduatno*. Although the estimated mortality mat for eaneer dur to aabosia* axpotur* tit not complatcK comparable ta the total actual aeeidonttl fttalitis*. tho renew it dearly useful ta showing that ihe magnitude of the eabeatet nak is grave On* example ef predicted eaneer risk e* t result of occupiHonol tspoture n tho followtni cancer nak numaiad from j: f/iO *ss DUP 0907163 DU 028264 occupation#! ttpoeure >o wniting mdidion. Tht tstinuied caeca* canetr falalily rale from tr irxn ef nniut to _h mtaunum permiaaibl* occupational axpoaurr lo lonirn* radiation (5 rema) li Uloaptf 1000 worker* (Commute* on th* Siufogteal I.The:* al Ionizing Radiation (BEJRI Ui prediction*, it* 41 FR 1*021. However. meat r*diat:ea atandard* (unlike OSHA standard*) require that exposure limit* be reduced to tit* loweat lovti reasonably aetievebi* below tit* exposure limit (the ALAAA principle). Approximately IS percent ef natation worker* have rxpoeurea Itea than one-tinth tlw maximum permitted limit The tie*** canetr deeihs at one-tenth tht permitted Itvti art I t to Li pr 1000 worker* tzpoMd 47 ytara. Aabeatos tipoturt* at U yttn to 2 f/ec trt prtdiettd by CSKA to ratull tn *4 tieatt canetr dtathi per 1000 worker* beginning work at eg* 2S (Ex. **-J*2|. OSHA't calculation for tht average excel* cancer riik to workar exposed at condition* that exiit In th* workplace today (for thoa* tbov* 04 f/ce) for a 45year tipoturt. i* 1M tic*** canetr death* par 1000 worker*. Tht* figur* wtt eaicuiattd by taking th* number oh* caecar death* tttimattd from tipoturt ' < -to ixtttlnt condition* foe*Syotrt for . ' ' 4host worker* exposed to greeter than ; 04 f/cc of t tbatioi end dividir* by th* number of worker* axpotad t* asbestos greater th*n 04 f/ec (muitipiiad by 10001. Therefor*, the exeett cancer riik at 2 f/ec for aibtttoi worker* i* attinutad *t tier* than twice *t high at th* maximum permitted radiation eancar iit and about 2S time* higher than th* eatimated canetr rick af I) parcint of tht worker* txpoaad to radiation. At (xiatini coP'litiona. aabaatot worker*' ixcat* eancar rtaka art tatimatad to be 15 tin** higher than th* ancar rttk facad by IS percent of the workar* exposed to radiation. Tht nak af tsbtatoitt further iacreeaet the iigni/ieanc# *f th* riik from oaboatoc oxpoaurt. At 04 f/ec. OSHA ottiaiatat that 17 exeta* eancar death! will occur ta 1000 worker* axpoaed 4* yean. Thi* riik io approximately 7 than* higher than th* eaaeer nak faced by IS portent at tb* werkura exposed la rudiuuen. OSHA find* that that* comparalivt rieh* airongty support OS) lA'a finding that worker* eipoaed to aie caaeentratian* above 04 f/e* art far aba** the point of xiBnificunt nak aad art at pita dancer of dying (rows cancer. S. Cundmijn. OS) lA'a finding of 'crave danger' ia tweed an evidentiary and policy eunaiderutiun*. OSHA * daterminanon that th* magmiuue al ih promulgation of an ETS utiing j o.i f/cc (One led rtak to eipoaed worker* i* Untimely Ki*h canatituiaa th* mater compenent al th* 'grave dxngtr' finding Th* overall txtriordinary de*r*e of rttk. th* extent that very high rtak ia foupd tn many aabeiioa uam( tnduatrea. and the unuaualty high duality of the deto utiliced to auk* the** assessments preaent * very strong mdeniicry beau fora 'gr*v4*itgtr' (lading. fuat a* importantly. the uniquo (rivity *i aibeatoe-causcd diaiaiet. in particular cancer, auch a* meaotheiiom* which ia linked almoat ixeiuaivtly to eibeaio* expoeur*. strongly support* OSHA't findini of (rive dan|r. Alio OSHA s companion af tho rttk of aiboiioe.roiatod disease to other laduitnd rtak* underscore* th* extraordinarily high rl*k estimated fee label lot expoturt. OSHA hat ata* aottd the concern* af worker* (bout current workplace condition* and tho numerous petitions far an ETS from uruena repreaantini many expoaad workara. Finally OSHA hat relied on its expertoaee la evaluating and rtfui*tine workpiece hazard*In recognizing the PEL may avoid S7JS uncar deu'h* <i<uming 10 >rt ixpciur* to iiimiiui of ih* current workfares at current conditions and 7*15 cancer deu'hs illuming 45 yian lipeture. OSHA i* aware, of course, that Section t(e) ef tho Act limit* th# ifTaetivt ume of an ETS to i months, and OSHA conclude* that a gravo danger aiiat* and aa ETS ia etetsaery eves if OSHA focuses axciuaivr'y oa this ail month period. However, the Agtncy believe* it ia appropnat* to caleuiat* bonefit* danving from an ETS using lifttime rtaka from 29 and 45 yean ef expoaur* to thi PEL of 04 l/es Mtobliahtd by th* ETS. Although the ETS iiput* within g mootha. Section e) requires that rulosaklng on a permaaiat attndard also bo completad within I month*, so that thus will he no gap in protection far exposed empieytta. la OSHA'a expenenet and ludgmanL complying with this statutory diroctiv* and completing rulamaking for a ptrmanont standard withut ( months of an ETS has and e*a be don*. extraordinary degrti of rtak eumatly OSHA lao babava*. btaad on it* faced by asbestos worker* end in experience. that it la very likely that the determining that aur h rtak eonatitutea a PEL isublishcd after t(b| rulemaking (rave danger to those worker*. wtlli* no higher this 04 f/ec. tht El'S I Naod foraatTS Uit. Therefore. OSHA boliove* that th* ETS will mult in * reduced lifetime OSHA haa determined that this ETS Is worker expoaum ef 84 f/cc or lower for aactuary to protect employees from 20 or 4* yean, and that th* benefit* grave danger. th* ascend prong of tho derived from that* exposure reduction* Aet'a teat of OSHA't aitreitt of its ETS for these time petted* tr* appropriately authority (Section #(c) of tht Aetf. At attributed to OSHA'a promulgation of explained in detail, th* effect af this ETS - this emergency standard. t* to lore many livaa which would e. Employ** Expourat. To danve otherwise be lost to aabestos.releted disease if current working conditions thesa estimates of numben at lives saved. OSHA depended oa <ia were not changed. OSHA boliove* that employees can be adequately protected against this grave du.iger only by issuing knowledge of th* following factor*: (l) The employee expoaur* lew)* from :h ambient asbestet air cpr.eintratiens in an ETS. This is because no other Agency the workplace: (2) tht number of action and no other fortsooabl* event would mult in sufficiently rtductd asbe*toi exposure* that would alltviatt the grev* danger. Farmer, the pravtcions qf-th# ETS ere tailored to effect tb* nacaaatry exposure reduction* worken raposod at the vinous asbestos levels: (3) th* duntion of tht exposure: end (41 th* probability of the duets* lor tho risk) aaieciotod with tho eumulatm expoaur*. egpedttieufly. 1. Live* Saved fry fttuinf on ETS. Employee exposure level* are , conventionally metaured *n ttrma at th? OS) l>\ ha* estimated the number of number of asbestos fibers that ere S deaths avoided as a result of an ETS microns *r men in length in one eut-ie which would reduce the PEL lo 04 f/cc centimeter ef air. f/ee. In these term an fit* 1 able* 2 and 1). For cancer only, ambient concentration may term to be a based *<i centmuing axpotures under small amount of asbestos. However, m Cimntly existing condition* for t physical terms. 24 f/ce equals 2.000X3 month*, tht potential number of live* filers per cubic m*ier (f/m'| Hununs saved ia estimated a* appraximetcly 210. Baud on continuing exposure* *t eeirrntly exiitmg condition* for 1 year, the potential number of lives saved i* estimated t approximately 42b. Also. OSHA has estimuied that the Inhale about one cubic meter ef nr per hour, depending on degree e? physical activity. Thu*, at thia eonecntruiinn. a worker would tnhuie rough!} 16 txXl OOO fiber*. I eucrons er more in kncm. over to tight hour workday J O o Vw W DUP 0907164 DU 028265 14033 Fedors! Remitter / Vot. 41. No. ns / Friday. Novtmber 4. jam / gulc* inq Krcuienons Nm CWpeeauxt tm in* Manna! prtcru. Tt I* riMWOMO lAJttuinol 4IUTXI0X fibers tee* Hu* t twrent tenet* stay nw be mtuled. tunmtsf that r* *4 uKum ttiMMM fiber* " l** nun i mteroet. OSHA continues is A* ths itrm. f/es. for easvemtne* but caution* tKui th* numerical aatimaia* 6f air concentration* given m ths** term* *r only tot w*y viewing asbestos eoftcssniitfl* mb should not bo evalaated without initrprtting tho auiO( of tho OSHA otad existing information to ntjoitt worker tiboitei exposure in toeb *fleeted industry. Oott source* included government eontrieior reports (Ex. te-CB tnd Ex. U4M). vsriou* studios rtportod In the litenture. NIOSH Hosivb Hsurd Evaluations, tnd OS' iA compliance data (Ex. <4 MU OSHA. rtviswod th* information, and dsr dad to aso the ltlO Restored Triangle Insututt (RTI) raport (Ex. a* the primary basis for sxposura tstimates because tho RTI astimatas appear to OSHA to bo the most comprehensive. In addition. RTI used a Urge number of difftrant data scarce* to malt* thair sxpesan astimaias. including *" interviews. existing documentation. and '. induatnal hygiene surveys of worksites * tleing*tha RTI repeal as th* primary ' reference. OSHA compared RTI data with other exposure information available for each industry For exempt*, spoeifie report* wart found for ssbcsies eemont manufacturing |Ex. So* 24$). itxiii* manufacturing (Ex. S^ari. removal of sprayed aabaatoa maisnal from.buiidmts (Ex. **-!! and brak* repair (Ext II-711. SO-USI. Tho Asbestos Information Association provided date concerning txposnre* durin* field fabrication tnd inatillaiian of asbcsioe cement pipe end sheet in controlled conditions (Ex- S4-J8J!- The Environmental Sciences Labors lory Xx. 14-402! alia made bast astimata* of wader expueurt in varieue Industrie! for tun. "in addition. OSHA used it* own field i-ipeeuon axpanence te tetimtte .xposurea. OSHA revtawad aelactad ease files and obtained infarmaticn that Usttd OSHA asbestos measurement* durtni eemplienea inspection* from l/i/ 71 to l/lt/13 (Ex*. S4-1S4 SA-US). OSHA tdjtuted tho RTI estintet* as appropriate, bated upon a qualitative (udimant as to which data beat represent iisttn| exposurt conditions. OSHA's expesure estimates are based therefore, upon * substantial date base end epos considerable expensive m enforetni the existing asbestos standard. OSHA seed the employe* expbeur* lev*1* in each industry te calculate th* number of deaths avoided by reducing th* axposura (rent currant levels to the emerteney hL. Alternative exposure distribution* used for sensitivity analysts will be provided in ihe Preliminary RejuUiory Impact Analyte. OSHA believe* that th* expes.tr* estimate* ire rote lively |m4. |tven'ih* state of the art of worktr exposure - estimation techniques tnd dots available today. OSHA is net twin of any ether avaiietil* current exposure estimates. Induatnal hyjisns report* of operations in th* seme industry, but tt difftrent work tiles. Invariably report different asbestos sxpotum among th* worker*. OSHA revtswed these repora end atede decisions rt|trdirt| tv picsl industry practice*. For same optrutiora. such to brake relininf. several report* wore available with templet* descriptions of tho working environment tnd OSHA was sbi* te uto these to make direct exposure esumites. Other reports, such at `Removal of Prs-fcnned Asbestos lasultuon' (Ex. M-2S4I. described cartful prccMtst for Siberia handling that did not appear representative of (ho methods used throughout industry, since ths reported air eoneentratient were not constates* with ether repent showing higher exposures (Ex*. le-Md. K-1621. Tibi* l shews OSHA's titimattt of smpioyee expeeun to asbestos by industry segment. use mm ww-M-e 4 DUP 0907165 Dv 028266 MBfilSm -IBMIillgli#; HMtwiHMBvBligaESlSliTtjitWHSiBii t i-sMife- atMSiSS^m&kMiimi&Z^mmmmtiMSZSFZ&SSrZBSXrZ^G; I (.Hi iL **lk MW*" V < i1 ! lii l in wt 1 i --r o <3 O * 5* at 5X s*a* 2aa i! * ---* *** $; f 55 s*s *S? sss sas DUP 0907166 J2 DU 028267 510M Rctiittf / Vol. 48, So 215 / KfilJjy. Novrmln'f < iHha / Knlri ,.mi Kiv"w I* Aifettlvt MIA llllM U #1 l a f l l f r f 1 OUP 0907167 j:c7:3 DU 28268 0u from OSI IA s Management Infumsiion Syvtcm IMIS) imJudct s Mat of in taoestos samples reported by OSHA field tuff during fun* 1. I97f to May IV IUJ (Ex. 5+-3S4I. Ovnng this ptnod. Ml eighl.hoA1 timo>wei|hitd avtrsg? (TWA) samples were collected in many different industries. Of th It* i ampin. ware below OJ f/ee 114 |18.N| felt between M f/ue end 10 f/ec and (2 |(JS) were above 4 f/ee. OSHA alao renewed the MIS summary ripen where the measurement date wen (rouped within Standard Indualriei Cede (SIC) dotufieationa (Ex. (4-554). Ait these date contributed te the development of OSHA'a beat exposure esttmain. In conclusion. OS!IA has used Its experience in enforcing the existing asbestos standard to determine the best estimates of worker exposure in the industries. On the whole, in comparison to other taste substances presentthe workpiece, asbestos exposure Information is well reported. Given that OSHA experience is considerable. OSHA believes its astimetas are resaonibla and appropnata and provids a satisfactory baatt for judgments ,' regarding the extent of risk existing in workplaces. OSHA acknowledge however, (hut the exposure information eoncoming asbestos removal and renovation in the construction industry is loss certain than tht other estimates. Despite uncertainitiaa in qualifying axpoetara In the demoltuon/remnvai category. OSHA faeis that this beat estimate te baeed upon evidence that is both reasonable and the best available. Furthermore. OSHA believes that any changes mads to (hr estimite as t result of the anctrteiniiiet would not bo of o suffici. tegmtudt to warrant a change in its basic findings. 2. Calculation of Ltvot Saved and Dittos* AvoiJtd. The benefits provided by this ETS constat of cancer deaths and disabling asbaatoaia avoided. The animates of deutha avoided by lowering o', the exposure linut by the emergency temporary standard uro baaed on the mortality retee developed in the risk aiaeaiment discussion. To generate the eipecicd number of excess deaths ttinbuMbie te asbestos m the UA workforce, the expected rate ef mortality at such exposure level <*< multiplied by tht population exposed et that level. The expected mortality rate from each exposure level wits derived from OSHA'a evintitutive nak analyata (Ex. 04-312). Tht expected number of fra tht at the reduced PEL wet then subtracted from the expected number of deaths at the current worker exposure levels to Otiarmina the estimated number ef deaths avoided by reducing the permissible expesure.'linut. The bentfiti ere expressed in terms of ttumsttd daathi rethar than ditabillty becauta the tj-pta of canear aaaociattd with atbestot exposure hava a vary poor survival rata. An txamplt of such a calcalution follows. To catcuiato tht lung cancor deaths avoided during ono ytar of exposure to e worker population in the construction industry who art engaged la the installation of atbettoa cemtnt sheet; Population* 17(5 (Table 1) Estimated Current Exposure Lave)* LO f/ee (Te bit 1) Estimated lung cancer risk for one year at 2 f/ce-144/100.000 (Tablt U) 1. Calculate expected deaths far Inttallers ef A/C shtat having one year of txpoture at 2 f/ee txpoauro level; - Population x nak-expected deaths (17M)(lM/10ai0)-XMaf . approximately three daathi among tMtailara. 1 Calculate rxpecttd deaths for installers ef A/C shtat at PEL ofO-S/ee for one year of exposure . Eitime tad nak at OJ f/cc-M.1 par loo.ooo (Table 17) Population x nskaaxptcttd deaths (17(5) (55.1/100.000) wO.M or approxunaie'v one death among installers A X Calculate run* cancer dsatha averted or liw. saved lot A/C sheet installers by reducing exposure to OJ; subtract expected deaths at OJ f/cc from thefts expeeted at 2/f/cc T2J4)-(0 Ml l J ar approximately two live* saved. ' The estiaieted benefits derived from , exposure reductions to several PEL'S which OSI IA it eansiduring for e final standard arc prevented m Table 2. These benefits represent the estimated number of eancer deaths evoiUcd from tho*c expected Cue to 20 yaurx txputart at the estimated current exposure ic\c j sssuming worker expeiurt aep.m .n ace a. The benefits woru taiculuted uune < base of U yeer* exposure because, us stated earlier, to years ia an eiiiminc of typical lifrtimt axpoauru for soma workers. Exposufts of * months, ant ytar and 45 years duration art also used to show tht pave dinger and the need for the standard, based upon a OJ f/cc Pallet Table 1). For Table t OSHA basts Its respirator assumptions in the construction industry and shipbuilding Industry on its enforcement experience, an its familiarity with the industries, trade unions, and Industrial hygienists, and an available studies an this subject OSHA believes that thaaa tatimtttt may overstate the depee of respirator use. This would lead to underestimation of benoflts of tha ITS far tha following reason: The fewer wcrktri in compliance with the current requirement* for respirator usa for ambient sxposures exceeding 2 f/cc. the greater tht potential benefit* from an ETS mandating that workars ba trained regarding tht significant risks from asbestos axpoauru and tha importance of using respirators. Also, workers eu7T*m|y'uiing rtspiraton will benefit by further reductions from 2 f/ce to OJ f/ct. However. ifresptrators mandated by tha ETS are not used properly or consistently, then tht number of eancer deaths avoided ia an ovtrestimatt. . To tost the rosalta OSHA also calculated the benefits assuming tht: til shipbuilding/rspsir and construction/ renevation/demolition operations eomply with tht current standard. All of 'ha ihipbuilding/repatr warkars wou i shut ba prottetsd by respirators hie.*, would reduce exposures to 0 5 f/ec. The construction workers would have en exposure of 2 f/ee. Tht benefits of reducing the PEL to 0.5 f/cc would, therefore bo caleulottd at tht difference between expected deaths ot 2 f/ee er.c the expected deaths at OJ f/ee for at! workers in those segments. Table 4 shows these benefit ttttmattt. uus etoc I1IMM DUP 0907168 DU 028269 (*! J (ItllM H S t f tAACIA HAIM A*IHO M H * lllllla i r lU M IlM U l ! i<A M xn * 51096 Ftdttit / VnL ig, Nu. ::S / Krniay. Nj\itv..cr <. ',9IU Ru,cj nu -vrfa............ --M------i-- ii i i it 2 M*tf 2 *1*** *Wi . 31%Jp** = * 5 *-- 2** * - "5 * a * aS f f i, 2< fIs w%I NSC tf 1* ib* :* n^ u* ini! 3333 * S* . 5 *N ; 5 ItAlc 2 I t t M I H # A il t M *r B ttlM I n l M l tfcrc* fU > * _______ M U rtW 20 I W I * lauf -------------- --------- t fi 1i mt 3 t t Il m l ! m i w DUP 0907169 J DU 028270 Fadtral Ragman / Vol. Although lh results m Table show fawor benefits OSl (A behoves the number of deaths avoided under this eeenem AO for in month*, iflj tor j year. 2411 for 2d years. and 3813 tor 43 yean indicate a grave danger and necessitate (hit ETS aeuon. J Tula 4 I Caner 0itns Avoided nth 4 o.l f/ce ETS Aiiuaing Coopt tenet aiu tnt 2 f/ee Standard Industry Sector A aontht 1 year Frtnsrjr Mnuftcturlng 2 1 lU Secondary aanufsecuring IT. 31 471 Automotive After*arttt 4 1 134 Shlpbutlding/iepttr* Constructlon total 00 57 Hi to 1U 0 1884 24IA 20 yt4ri 45 /tirt 174 AH 154 0 2451 3513 OSMA attunes tnat tho ontlro Industry tocter csnplftt itfl f/ce standard through uso ST controls or rttpirttari C10U rodudng oapoturo ta O.S f/ce. **OSMA uiufot that tnt renovation and dansl Ulen industry 1actors tri prsttcttd ta 2 f/ce by ust of half new air purifyin} rt1rotor*. ].. >'o OM.. Agency Action It `.dtquatt To Pnttet Emsloyttt Aftirtt Thit Cmrt Oanftr. OSHA bahavot that Congress intended (hat tho ETS aothority may bt taarctaed whoa OSHA dotarminot that a grova dangar to presented and whan tho provtoiona of tbo ETS art eroded 10 bo an Immediately effective mean* of protecting tmployees against such danger. OSHA. howovorfba* tvalautod the potential capability of other possible acnonj to reduee tbo. rtak from asbestos exposure. OSHA baa dotenmnod that no ether agaaey actioa abort of toouin* this ETS which compels aa immediate four fold iiptlM ratlucuea will luflietentiy protect onffusaro againai the grave danger of developing tibestot related disease. la making thia determination OSKA eonsiu/red the usefulness of atapping up enforcement of the current tibestot ita.-dard. and Initiating a Sib) rulemaking proceeding to permanently reduce exposure levels. Those actions will bo diieusttd in turn. OSHA notoo that these actions ore aat mutually axdusiv -and in fact. CSHA it both flapping up its enforcement activities and amborktng an a required Kb) rulemaking aa eaordtoaicd activities in addition ta issuing an ETS. (a) OSHA first eoneludaa that merely Increasing nt enforcement of tho eurront aststoo standard would not sufficiently reduce tho grave risk of asbestos-related disease to exposed worker*. Evan if luck inettased enforcement rosulted in immtdiattly uniform compliance with tho currant} f/ee standard in ell industries, risks la asbeitst-cvpo.tii worker* would rttnain unacceptably ki*h. As tutad above. OSHA has estimated that at a 2 f/ee leva) employees ttposed over a working Ufebma of<3yiar* are prodietad is hava n axetit mk of dying from cancer of *4 ta 1000 and of eontraeimg duabbng esbeitssii of SO in 1000: fmplovee* exposed over id yiar* are predicted 10 have ucm cancer nek a/ 44 in 1000 ond 1 diiabling iibostoolo ntk of approximately fi kt 1000. Erie at exposures luting one ytar. an animated I ampiayets eui af 1000 are predicted 10 die of asbestos misled esnear. and thare i* also additional risk of developing esbaaioais. Kiska ei the 2 f/ee level have been eekaowltdged aa unaeetpiablt by etbtr government! which have reduetd their permissible levels below 2 f/ee. To estimate the dumber ef livts at ataka if only the current standard ware Immediately enforced Instead ( compelling a 05 f/ee level through thia ETS. OSHA made other eeleulations using certain aacuapuont theut actual compliance levels. For this analysis. OSHA assumed that all construction, rtnovation and demolition operations comply with the current standard to that worker* in this Industry would have (xpeeurea ef X lice. The difference in the odaber af deaths evoidtd by compliance wtth the 2 Vet standard compamd with these avoided from compliance with the 0.5 f/ee ETS is still very high and ihowt that asbestos exposure even st 2 f/ee represents a grave danger to such expeted employees. Tibia a tat* forth the results of these calculations. Thus, for a 20 ytar period at exposure. OSHA tttfmttsd that manly ..itunng compliance with thi current t (let limit may east 241! employee* their livea- For one ytar at expeeura. OSHA eatimatad that 182 employees may dis if axpesurts art not reduetd ta 05 ties, tasursing full eemplianea with the current 2 f/ec limit. OSHA beiicvtt that these benefits (i.e. lives savedl represent the lower bound of those that would result from the ETS for two reasons. Half mask respirator* which may be oted at air concentrations ef 20 f/ee te comply wuh the current standard may not ifT*en\c.> reduce employee exposure below 2 f/ca Further under the ETS. half mask ratptteton may only bt used m workplaces where eoneemrations do not tiered 1 f/ee. Employees in workplaces between } and 20 f/ce mutt use mere proteeuve respirators under the ETS. hence, it it likely that ihrir actual DUP 0907170 I T "> n ' DU 028271 51090 Federal Register / VoL eg. n0 \ ynday- Novnmbor 4. iwj / Ru|rt and Rpgtrlj;,on exposures may be reduced to heluw o.S r.'cc ind the benefits ef the Cl'S will be correspondingly mcreeseei. Further. an ETS by nature ef the eetutc itself, end the accompanying anfortmaeu program, will andouOtedly boon tie incentive* to comply with sfl protective previsions of th sibtttos standard. (b| OSHA reiectad rely rag on merely beginning Settee Mbl ruJaraaktng proceedings to revts* the standard Is reduce the TO. it en inadequate reiponit te the pttr danger field by asbestos-exposed worker*. Beginning rulemaking proceeding* reeuiu in no Immediate workplace ehnnge*. Employees would slit) continue to be sxposed to thow eondiuont which define e (rive daayer for el teaei the pendency ef the rulemaking. In OSHA'e evpeneaee. cempletini b| rulesiajunpf not imteted by in STS coaeenunf beterdous substances ten lake many year*. Far eaaaiplt. the cake ovaa emiiuaa ttandard took approximanly JH years. the lead standard. more than I yean tad the cotton dust standard, more this 4 yean These pened* do not inelude say of the additional delay* m the affective dstat ef OSHA Menderd!* that were due to judicially imposed euyv whiqji have resulted ta delay s kiting sritanl years. Under the most favorable emajuneea. however. OSHA bafcavas that it Is possible that a section 1(b) rulemaking limited to the issues ratted herein might be eompictad in approuseteiy ose year, abicni an ITS. A* shew* above, the Mtimated riaka of dcvelapmt tibettot^eiated center due to espoeare foe one year under torrent condition, ure tt.ll extraordinarily hifIs. The additional nks ol deveioprag asliesiasia due ia one year s eipoaure under current csndiiioca. althou|b quantified with tees certainty. are also more than significant. OSHA sisa believes that the risks of sis months exposure, approximated by taking ex er half of the one year riaks under carrent condition*. alea era umicetpiably hijh. OSHA amphaima as staled above, thus OSHA'e cxperiracs showa that wuheat aa ETSL proceedings ieidin| ta a parnuncm hraltk standard ara unlikely ta be enmpHitcd wtthm a sis month penud. The axptaaatiaa af OSI lA'i capability to produce a standard within muntha of an ETS lias ia the urgency generated bv OSI lA's findtos of s (Wave danper. the exiaianca af a specific statutory di-udliiw tu complete a ruUauikine within t monikx and llir need to prevent * s*p In protection betwren the espiMiwm of ti.a hfS end ihe impueition of ihr permanent siend.uxl for s substance already determined lo present F*v denser. OSI IA also believes that It Is helpful to evaulate the extent of risk resulting from lifetime exposure periods of 20 end 43 years in ths absence of this ETS. As shown bt Tabltt 10 and 11. these neks ere extraordinarily high. 4. Oifitr Fatten InAeatinfa Vssd fat sir 73. Although worker eapoiure to aibestos hat been declining over the years. OSHA believes that exposure conditions will continue to present F*v* danger in the near future unteas an emergency standard la promulgated. OSHA basts this finding on its evaluation of exposure information, asbastos use statistics, consideration af the nature af industrial exposure today, and tha degree ef compliance with the currant standard. Although OSHA anticipatta a deciina in ust of asbestos In products, this daelint will not materially a/Tect sbestos use in tha near future. The xttnsivt tort litigition regarding asbestos end the awerenesi af health {Tacts associated with tsbesto* exposure provides strong inducements for producer* end ueers of products ta witch to eubstitvtee for asbestos.hn * fact ashestts consumption hae declined over tha years as shown; (ensidipttan Tear lattern (1000 tons) 1*7$ 1*71 1*77 147* 17 lM ttll 1IU iii 34* 372 31* 331 230 Mf 2< Worker usiiattus exposures will eenitnuerhuwfssr. for itwny year* ia the futura liccause substitute* fur some products do nut appear immeduxi-ly avinl.iUte. . For oilier products. oUl rndaci-nirnt parti will be nredf* fur many rears For example, automobile manufuciurvn ir.aj twitch to nan-eibcxtoi bracts ano dutch facing m new vriiieles m in* next several years. Old vehicles, containing .ssbestes parts, will remain In use Tor many years thereafter. p4,k ti al. found" ovtr half of all eiultistory buildings surveyed (H out of 1?) eomiutcd sprtytd aa asbestos metenel [tx. S42*2). Tha patenrial for asbettot exposure exists is long is stbesto* remains m thasa budding*. Renovation work m (he building such si reloeatmg wills and eltctrleal wiring will result m continued exposure for carpenters, pemiers. electricians, laborers, sheet met.il worker* and oikere. Therefore. OSHA dees sot believe thet ms|r exposure level reductions tea bout to occur in Ihe near future. The trend towards reduction in asbestnt use end asbestos exposure has b*vo a slow gradual procass with the exception of instance* where ths government Intervtned. For example in Iff) the EPA banned ust of sprayed an insulation containing mare than 1 percent bastes. Without OSHA scting it this time. OSHA predicts that the grave dinger conditions will persist, certainly during she period required for OSHA't usaenes of s 1(b) steadied. end probably for many years thereafter. 3. 7Te Weed far the Sgteifie Ptavtttot* af the FIS Tha provisions af tha ETS require ths employer to use any met bad of control to reduce employ ee exposure toOJ t/ccend to train workers concerning the hxxardi associated wvh a theties and procedure# for reducing Ut* nek. That* previsions'must be Implemented immadiaialy OSHA believes they ire greitly needed to sfTord employe** mesningful prelection Al the benefit tatnon explored in detail, compelling exposure reductions through an ETS will result in s great number of Hvet saved. In addition, et staled earlier OSi (A believes that its eelimatas of the degree of Cvtmp'i.inee with respirator requirements in the construction anil ^shiphuildmg industry may oversi.-'e th degree uf present respirator me. Thus. OSHA may he understating the benefits to lie denvvd frem an ETS. ar.d henun tha need for such an ETS tn lit promulgated, in addition. OSitA't estimate* of exposures in riemnuuun and renovation srsmerts of the cor.stmctliin tnduxtrv art iippmximui' K gtl f/ix. Breawaa undvr the EPS ihe l`FJ. is luwrred 1* CJ tier-. the airborne eanci-ntruiiun at whti.h mufv prmri tiw- DUP 0907171 n / DU 028272 fdnl griper / Vpl, 41, ,ya jg / Fnduy Nnvct~-.cr 4 <fl4j , kuici una ws. I <JI. )1UJ1 re ipirtiora (with 1 protection factor exceeding 10) mutt be worn drops from U f/cc (10 time* the former PEL of 3 f/ cc) to i f/n (10 time* the new PEL of 04 f/et). Therefore OSHA believes that mart worksr* will ulif more protective respirators under thwETS than uadtr :h current permaae*t etanderd. that their actual exposure Itveil will be reduced la below aj f/ec end consequently that their risks will bo reduced ovia wore then the calculation* ladle* it. OSKA finds Im that requiring a Wining prairaai to bo matituted at quickly at possible it eat of the neat effective method* of aaximixini the bonofieial impact of the exposure reduction and of ail the protective provisions of the currant standard- That, the content of thia CTS haa beta chettn at the meat effective short-ierei <trete0 to reduce atbettea riaki which will be accepted and implemented. 1 Condition. OSHA Bade that workera exposed te atbutea in the workplace at exietiit| exposure conditions need tkia emergency temporary ttendard to protect them, tram the trove denier presented by . these condition*. OSHA And*Mul by compelling e reduetea la exposure te OJ f/ec fer these tmpleyeee presently exposed over that level many lives will be caved. Training imposed by the CTS will enhance the nah reductions, aithevth qucntifiectten cf that additional reduction carnet bo calculated. S.S tits is the lowest feasible level achievable through thia emertency action, where ihort-term implementation of th1 control* 11 required. Only by issuing an CTS cumpeilint reductions in exposure levels below the current permtasihle Itmit of I l/ec eon OSHA brinf about adequate reduciiece in ruk*. The administrative eetiea of stepping up enforcement of the current standard is an inadequate response t# OSHA'e finding that ceirant conditions present e grave danger. OSHA does net believe that any ttgnifaai redweden will eecxr within in acceptable tires period without thia emergency standard senate OSHA haa oUcivred a gradual reduction in sbnkM use. but. la die Agency's experience. significant and rapid exposure rrducueas eaxolty occur in response to ssaadards. The provisions of the CTS arilt significantly reduce the nak end reduce it quickly. Thrrrlort OSHA hits determined that the CTS it nncnstxry te reduce the grave danger. tv. Occupational Heallk Data A. Introduction 1. Atbottei-rtlattdOiteetct. Ashastos tx pa turf ten cause s number of dissbiing snd fttcl disesecs. Among these dictates ere lung eancar. cancer of the mttothtlial lining of the pleura end peritoneum, end atbsitons. It Is else likely that atbetiot tncrteita tha ntk of gaitrolntatunai cancars. Of all tht dictates caused by iibettea. death from tune cancer eonsti(u(ss the greatest health rtak far American asbestos w orkers, lung cancer has been responsible for ovv half of the txctaa mortality from ttbeatoa exposure in tome occupational cohorts. Tht relationship between lung easeit and asbestos exposure be* bees established by numerous epidemiologic studies of diverse groups. Asbestos* Induced lung cancer usually ha* a latency period in exesaa of 30 years and may be diagnesed at an aerlier aga than for aon-expoted persons (Craighead at el. 1912: Ex. *4-033). Few cases of lung eancer iro eursbls despite adveaces in medical and surgical oncology. Only f% of lung eaec' patisnta survive five at mere year* after diagnosis (American Cancer Society, tUh Ex. 14.110). Asbettts exposure acts lyxergtiucslly. with cigarette smoke to multiply'the risk of developing lung cancer. Mesothelioma also has boon' oonciuaivsly shown to bo associated with tsbottos by many stadias. In soma tabestos-expotad occupational groups. IQSUIS* of deaths have been attributable to malignant . mesotheliomas. Melignom mesotheliomas of the pleura end penteneum are extremely rare in persons not s-poseO to asbestos. Ceneretly. t latency period of at least 2S to 30 years i required in order to observe mesotheliomas in an occupational eohert. Some victims of mesothelioma havt had a latency period exceeding 40 yean 11p.ee their initial exposure to aibostos (Ouighead et el. 1(02. Ex. M 033). Thia farm of eancar is rarely curable and is usually fatal within a.year after diagnosis. There it so evidence fer e relationship between . cigarette smoking snd mesothelioma nsk. Asbestos txposurc can causa pleural and/or other pulmonary disease. Pleural plaques ere one ef the markers of exposure snd may develop within 10 to 30 years after the initial exposure. Plaqups era opaque patches visible oa chest X-ray* that consist of dense ttriindi of enllugen (connective tixsa* prutcinl lined by metothelial cells. All commcruml type* of asbestos induce plaques. Plaque* can occur even when fibrosis t* ebient end do not icce to reflect the twenty of puimunury parenehymnl disuse Pleural calcification is sit* eommemy found u person! *no have been evpated 10 tbetioi (Craighead et el. tutl f.-t 033). Aebesicei* Ji pulmonary /ibruaia caused by the accumulation of ubestes fibers in the longs. Advsrse affects of iibestoti* range from ihertnet* of brsoth upon ruction to eyanoiia. effusion* of serous fluid, respiratory failure, cordite decompensation. end death. Often, tebeitosif u a progressive disease, even m the ebstnee of eontinaed exposure. Symptume of disease ire thorniest of breath, crush, fatigue, end vague feelings ef eickntis. When the fibrosis worsens, ihortntu ef braeth occurs tven si rest. On* elmieal feature of early ssbtstoei* at well ts sthor lung dietsses is tnd.intpirtiery erseklst (rales). Oiugnoitt of iibetiotii la bated upon the pretence ef characteristic radiologic changes, symptoms, rales. othtr clinical fttiurts of fibrosing lung disette and * history ef txnotere 10 asbestos. Cigarattt-tmstung asbestos workera may have an Inerotsed nsk of esbtsiotis relative 10 noa-smoking atheitoi worker*. (Crdlghesd et iL iggjrEx. 94^33). Sore epidemiologic studies heva observed increaMt in esophageaL stomach, cola-rectal, kidaey. laryngeal pharyngeal, ud buccal cavity eenctr*. While tha magnitude of increased cancer nsk for these sites is not is gras: as for tung cancer and mesothelioma, tho Increased risk le nevertheless of considerable importance because of the high background re tea of seme of these tumors in th* generul population. A SC", increase in common cancer such ts colo-rectal cancer results in many mo*e deaths than a SOT inereite in a rare dancer. Ceio-rtcttl cancer, it detected end treated in an early localized stage, hat a five year survival rate of about 70% (American Cancar Soeitty 1983. Ex 94-1(0) Surgical and madieal irettmer.: is leu successful for the ether suet lifted above. Adverse effect from exposure to asbestos have bean observed m wurktn Involved in asbestos cement pipes ins shingles mnnufaeturng'Enter!.ne ei H73e. 1173b; Weill et *1- 1479. PinkeUtein. 19*3. 1993] (Exhibits 94-123 94-133. 14-309. 14-044. 94-3401. atbritei mining and nulling (Wotfitr ei at. IVOO Lddell et el. 1977: McDonald et tl199tt Hobbs it *L ttOO- Niehiilsun et. 1179. Xubrno ei si. 19791 (Exhibits 2-:: 94-OM. S4-QSS. 94-133.14-073.14-tt.C) ssbestot tuitdt manufacturing (Oull. 1999. Pcto et t. 19na Berry et ul_ iv DUP 0907172 DU 028273 SHOO federal Reciter / Vol. 48. So. ns / Friday. S'avtwber 4. 1903 / Ry)c, lmj Regulation! Camant at <1. m3) (Exhibit* H^C. *41&g, It-OW 14-037). inaulution work (Salixart It li. 19711 (Exhibit *4-090). shipbuilding (SalikolT it iL 1971; Biol tl 1I,, I9ia Tignon ft iL 1*0) (Exhibit* *4-091 *4-109. *4-1*1). *1*1 In 1 unity of tsbtito* product* manufacturing induitnii (Jonti it (LIMtt1 lnd*r*ou and Entirlmi. 1171; McDonald and McDonald. 1*71; Saidman t *U 1971s Robinim iL1979: AehMon it ai- 19(1) (Exhibit! *4-131.14-Oil. *4-1*4. *4-0(7. *4-0(2. *4-1031. It should b notid that 3 ribiti par cubic aancitir. which i th* cunont OSHA itandird. i* teuivaltnt to 2 nuUien fiber* pir cubic m*t*r of ate. Beauit human* braatho in about * cubic SMtir at air every hour, depending on pbyaial txirtion. tho cuRtut OSHA PEL for asbestos allow* workan to inhai* 2 Billion aabasto* fibtn per hour during an *>hour work day. For ilia tako of brevity, aubaaquaat diieumon in thia prtambJa will cxprtia ixpoaurt in tarn* of 11bar* per cubic centimeter (f/cc) rather than fibart par cubic mattr. Nute.--Th* eurrani OSHA itandard indudai ubaitoi fiban f meoaatara ar mar* r itagtA. tk*r*by axduCing (hatter -- fiban. Suras up ta MU e! *uUama aebesuo . fiban aaa Mortar than I auerametaru weaker* may (shale p ta MO aufliao aabaitaa Ihin pa* haw *wi| an * haw weekday. Sine* OSHA'i publication of a natico of propoaad rulentldng in 11*9. additional itudiai hat* confirmed that aibaatai axpoiura cause* a high rtak of cancar. In addition, much more complete data on tht natura of dosa-mpont* ralationahip* (or aiboitoi-induoad ditiutai art now available. Thai* atudioi gtnarally indicate that tha PEL at by OSHA in 1972 ti Inadaquat* to protact aabattoi workan from either lung diiaata or cancor. The following agenda* and orgnnicationa hart raviawtd tha health data far aibattei: Intantaboaal Aficncy for Rmirth on Cancar (LAACI (1977. Ex. *4-ir). OrgantuUsti for Economic Caooaraticn end Cavalopmant (OECD) ' (117* Lx. *4-337). MOSH (197*. 19*0. Exhibit* *4-43* and **-aL Advtiary Comnutta* of tha Health and Safety Csmmmioe of the United. Kmgdoa (1971. Ex. *4-2ltL tht Chronic Hasard Advisory Panal a Aabtttoe (CHAP) (19*3. Ex. 4-3S(L tad tha VS. Environmental Protection Agency (IMS. Lx. *4-1*0). AD af thaea groups have canciadad that thert is a eauaol ralationahip betwaaa asbaite* expoaut* and the development af cancer and non* malignant respiratory diacaia. MOSH rocontmandcd reduction of the PEI. for taiMiitsi to 01 fibert per cubic centimeter (0.1 f/ee| m 197*. In tMO. l (tint NIOSli/OSHA Aibeitoi Wo.-k txlrapulation modalt r valid Croup Hated that then wit no letal of indieuteri af th* txistinc* af tignifie.mt rxpeiurt to ubiitoi balow which baiilh risk*. clinical iffect* did not occur and Exposure data f/equanily an not rtcommindtd a PEL of 0.1 fibir* per able canumetir (0.1 f/ccj baud on th* Lmitatiai-i af currant tachnologiaa of aeaiunng air cooeantratiom of iibaitot. Tht 1171 raport of th* available for warkars ixposad bafan ` iro. Whan histonal txpeiun data an available. tho data afttn have such Imitation* u having bean collected and analysad uiag induatnil hytnn* Advisory Cemaittte of th* Hatlih and Safety CommuHon of th* United tachmquaa no longer ta uaa or having bean collected in miy soma anti ot tht Kingdom, hereafter rtftrrtd to in thia werkaitt or having been coilaetad an tactioa a* tht UJC. Committte. ltd to th* raductian at thi Iritish itandard lor asbaite* to I f/cc for chryiotiia. a* tlce (at imositt. md 0-2 flat toe eroddclit*. only a ftw acasion*. Tharafara. af aaeaauty. ammatai af 4at*-niponit baaed on epidemiologic itudiai will have fairly broad rang* af uncarumiv. Cumc. f. n ippaar* that tht United KingduA may lower tha PEL for wvytottft to 0-S. 2. Evaluation tfkitk. OSHA** fint mp in analysis af risk of ditaai* from ixpoiurt to potentially haurdoua igtnt it a qualitative evaluation at scientific data. This evaluation involve* reviewing butaan and experimental studies to consider rush factor* aa overall study design, mtthodi of dau cailaction. biologic piauaibility at findings, csnsisttney of findings Iron diifartnt itudiis. ttmporal eorractnai* at th* uiomaBsn. and other faetera aa U at general laanufic judgtrtanL Subsaquaatly. aftir a specific agant hu baao judgtd ta be kaxxrdoua. tho OSHA nut lxamini th* bait available data on tapaturmsponit to amva at a determination of ligtufiunct at rule, daapitt inhannt tad mavtubl* uncart*totles in tho data. Tha cumnt *>bour tuna-weighted tvtragt PEL for aabaatat af 2 fibara par cubic eantimatar (2 lice) anviiagts that workan will act rtettvt a cumuiauvt axpeauro axoadiag 100 f/cc-ytan ( 2 dec x to ytara af ecsupatioaal txpMura). For aabattoi. OSHA btlievee that a number of itudiai auggtat that incnaaad risk of lung aactr. aibtstatta. and naiothaJioma bavt accumd troa euaulaiiTt txponns utiaattd u clsae to at below ISO f/ta-yau*. - quantitative ixposura-raiponi* Han. OSH* rypiMfly aw <* ytirs ralabonihtpi batwam tht sgattl and diaaatt an b* iitvtitigaitd. Tho available dau on air eahctntntiorti of th* tubiunct ar bielogieal India* of' ixpesur*. luch at fiber eantanti within lungi. un b* nviawad for cohort! of worktr* dimsaitritad to have aa tfc* parted af a Id! walkmg lilaum* far paapam af quanUfytng nik fnm aapaaun la ioxjc ignis. Far aabasm maay letnust* have ui*4 JO ytara ta itvttHM a full watkiaf hftum*. Thus, hath a* ytu* af iipatw* aaC lOyaai* *<#**<* n u<4 m thia aeeumew far tha parpaia af tiuiyxmg 4*a mpana* laiaUaRikiP* (ar ttbtsis*. inmtaad r...< of dutatt. If workan with aa obsar'id iseui nak of diaeast bavt rtettvid evunuiativi exposures permitted by tbs cumnt OSHA paimiaaiblt exposer* limit than a pottatial significant htaith ntk from txposuro to the PEL baa bats established. If the workan with observed axoan nak noivad cuatuiativt ixpoiurti above thoa panruttid by th* euRtnt PS. than risk from tho current PEL may b* estimated horn risk obiarvtd at higher laval* by aatng dosa-rasponia tairapolsuoo atodrl*. Tht itel ion. Epidemiologic Cvtdatiee on Ritk from Espotute ot too Cumnt PEL will discus th* extant to which axes** ntk haa been observed from low axpotunt to atbettaa. Section V. Quantitative Pick Anelyitt. will dlaeusi tht prediction at ixcati ntk from low itboitoi ixposurt* using doiaextrapolation moduli bused on itudiai obaarving exeexa nik in humans. OSHA In thee* atudias. tha cuaulatli* txpoturta taiullad boa expoaurv ievtit srtatar than tha cumnt OS! IA PEL at 2 f/ee far an *-kaur day. Far tumpl*. workan wk* aaamulatad 100 f/ccyaars eould hart bam tzyraatd to aa avarega laval of S f/cc far a period of 20 year*. Section 8.(33. below, disnisws tha tpidenuologic avidanca for nsk tom low txpoauni in mar* drill. OSHA baliavaa that a aiguifiaat health risk h*s baas obaarvad for eumulauv* axpoaun* that could b* accumulattd by workan exposed to no men than utt present PEL of 2 fiban par cubic anumatar (2 f/ceL Eilimatas at cuaulativt axpoiura ar approximation* af tatal doa* raetivad by a warkcr during the panod oi tmploymant involving expesura to atboitoa. Cunwiauv* aiposuraa ganarally an estimated by muiupl) mg tht varying intanaitita of axpoiura. mch u th* *>hour tim*.w*ightcd ivtragra. consider* that both nsks observed by by th* number of yaar a exposed. Moat Kudin nd ruis predicted by dose- tkoonas of th* mechanism af j c:": 9 DUP 0907173 DU 028274 Federal Reflet / Vol. in. Vn. nS / Fnuuy. Novr-Hw- imo / Ruli-e end Rif.i ..'tons JllJl soretnoucnesis uaum* that the nsk of mmsformunofl el target cull 10 csncer coils increases with mertasrs m the total dew. Exposure* raetivno tint inch * transformation bee lekcn place may nd th* dawlapmlru a! concur. out hair* net caused th* center. Thu*. in aome jisiineov unity foul eumuladv* axpotur* may ovarttoto the exposures aoflieient to produea increased eanear rtxk. Ter thia niton aema epidemiologist* emit th* Later yaara el exposure to a carcinogen tn analyaaa e( mortality la nlttioo to eumuitbv* BSNM In additiee to euatulativa exposure. Inrenairy el axpeaura can ba examined la raiauea la diiaaia. Lntenilty el exposure is a/tan approximated by * hour lune-weighted avenge* |TWA`s|. The OSHA PEI el 2 fiber* par cubic centimeter (2 f/ccl ai as l-hour TWA Hai only bean in effect unca 1975 At thia tuna. It dee* net appear poaatbla to determine whether intensity of axpeaura baa an iffact as ditaaie ruk laparat* from that af cumulaUv* upeaura- Thia la betaat* the eurrant 0511A PEI baa been in affect only tinea 2971 which it at* Insufficient period to ebaarva ~ axhastei-raUttd diaaaaa*. which , character!*tieally have lamp latency , panedafia axcaia of 2$ tear*). Aa dacuased In the taction. Que/tUiioth* MlaJt Anelyeit. it tppaara that duration efaxpeaura may hart an independent efTact on maaotholioma risk. Tht followini taction* analyte recent prdamtoiogie and axpartmantai studies end diacuaa important aapaeta el the oocupationai haaith data concemmf abet to*. M. Epidemiologic evidence an KisJt from Exposure et die Current PtL \. Convention ofParticle Counts to Fiber Counts. Currentlr. personal atballot samplet of exposed worker* are collected with a membrane filter, end fibers are counted using a phaae contnat mtooacep* equipped with an ayapiaet graticule. ht the peel panicle* war* counted rathor than fiber*, area aamplea were take* rather than paraanal ntiepiti.aad im|Im ware oellected using thermal peecipiuiten at eud|ci imping***. Theae paat isduatrial hygiene avaaomaadU ware expniaed in tuUioaa af parttdas per cubic foal (abfenviatod aa mppcf or mpef). whereat currant motauremantt art axprcisod a* fibtn par cubic ccntimeiar ai par miUilHar (f/cc ar f/nti). Convrrtiao at mauaurameflu from mpef to f/ee it not a aimple cutter of upplymp a ainql* muitipiicative factor duo to die difirnng work environment* tn which aampica were t*k*n and differing ajtnplinc methodologies. The factor for converting mpef to f/ee hns brm ittirtird ii reefing Itnm 1:2 tu tj depending an the industry iluduig bv the iciemmi :Kin* and Chu. Tx. 14-1 Hummed at J- Ex. *4-lT7: McDonald. Uddall. Cibba. Eyssen. end McDonald. Ex. 4-ow) far aaampia. using cenvartioe factora ef 1:1 to 15 a cumulative exposure ef 20 mpef-yran euuid rti(t from 29 l/ee-yaart to 100II ee-yaat*. Tht Inmh Occupational Hyjfqn* Soeitty Commitie* on Aabaatea conducted a itudy ef dual eoncamnttena mtaturad by currant methods and hittonc*! mttheda (Ex. M0241- Cenvtrateo factera for historical etethodi tc currant mathedt were l: 047. t ZJL and IX depending an the hittencal method. Far aabattoa mtnin| end milling. thit taeaoe will uae th* midpoint of th# rente ei eonvareion factor*: 1 mpefmill cc fat aibetiaa production and aabaatea eomtnt producuan tht* taettoo will use Hammed at *L`* suggatttd cenvantoa factor ai 1:1.4 for mpef to II cc. 2. Eoidtmtoh;tc Studies. Th* eptdamitiofic itudiea that OSHA interpret* *1 suggesting that significant health nak baa been obiarved at .low etbaatea exposure* fell into 2 . caitfoaiM: (11 Studiat of hooathold eoatecu at aibaatoa workart. (2) ttudiet of worktn whoa* expeaurtt ware abort* titm. and (31 itudiai af warier* with cumulative exposure* aatuneted to bo eloa* to or below 100 f/ee-yura Thia section sumnentes that* itudlei and * prwtnu OSHAi inalyiia of thaao studies. A but* ar of itudiai have obiarved mttethaliemaa end an mcraaitd prevalence af chatt X-ray abnarmebtiai ainoni idulta* #f uoaatoa worktn (Andaman at al- Exhibit* 44-Ci* and *4-017; Vienna and Palau. EX. *4-1*4. U at tL. Ex. H*im In addition, maaothaiiomaa have bun *b*er:*d in csmmtnity member* living nctr aabaatea mint* and factonat (Wagner at a). Ex. 2-21: Newhoua* and Thompson. Ex. 14-070). Aadaraan at al (Ex. 04-0141 obaarvad s * il l percent prevalence of cheat X-ray abnormality*, tacludini pleural thiekentni. plaques. pleural calcification, and irregular opeeitia*. among 111 houaahold contaeta of *monte factory worktn compared to a *4 partem prevaltne* of cheat X-ray abnormalitiea amen* 33a cantrola drawn from the tame community at th* amotit* worker*. Contrail war* matekad to tha caiat by ay* and tax. Aa al 1971.4 caaa* of mesothelioma had bean diagnosed among ih* 02* family csniectl nf the amoeiie work*i. PrtaunwUiy. f.imily eonuir.n rccvivu-j ihrir evooiure ia iibenui from duit tamed home on the worker 1 clomirc tipecially dunng ihe laundering of duiiv eloihe* Alioul a iKeld incraeit m prevalence of pleural thickening compared to eeniraJt wei obitn-ed in family eomacu ef werkan with enly ant year el expoaur* wuhm ihe ametite factory. Eitimatad aibeetei rcpoiurt leveli of family eanttett and community SMmbcre obiarved to be at nik ef aebeato* related diteaia have not been reported. CSHA eenuderi it ve*y likely that the cumulative axpeiurai ef the family contact! and cemmunity member* wen lea* than 100 f/ce-year*. Soidmatu Selikaff. and Hammond (Ex. 4-9*71 ttudiad the mortality ef 420 amoeita production worker* tmpioyrd lomotim* during IMMI. Se dman tt iL reported that dull concentration! hid navtr bean mtaturad in thu plant and that the plant w*i known to havi daficitnt ventilitien lymmi. Workart wera elaaitfiad aa having worked lota than 1 month. 2 months, i-s momhi. 411 month*. 1 year, or 2 or men year* Worker* in oil categories of length of employment had axeaasivt mortality from lung cancer. Foraxampl*. man tapioytd Itsi than one month had a long eanear atandardixed mortality ratio (SMX1 of 297. baaed en lupplememal autopay. clinical end surgical Informelioc. (Th ttandtrdited mortality ratio la calculated a* tht ebaervtd number ef deaths tn tha exposed population divided by the number sf daathi lhat would be expected in the expoeed pepuletion. based en mortality rates of in appropriate companen ospuiation TVr SMK ia fraqvtntly used at an approximation to tht ralativa nsk.) Hence. OSHA caanden tin Seidmen f *1 demonstnled that txetss lung carter-tk could be txpantnead even by worker* with exposures ef rtiatively shaft duretiex. ferry. Cilsen. Holmes. Utvinsohn. and Roach (Ex. I* 0301 studied the worker* ef an aabaatea textile fseiery th* Unitad Kingdom Btrry tt al. raportad la 117* that the evtrage txpoaun leva! was 5 f/ce and that 16 percent of men employed after 1950 hji "possible asbaatoat*." Among men ampioyad eftar 19S0, Barry et al ebaervtd t percent prtvaiencra ef cnpitatieni. possible sibestesis " n"certified asbaitostt' et 37. 4t. end 42 " ccysin mpactively. Sorry *1 ai concluded. 'In view 0f Ihtaa rinding* there Is ee room fer complecancy about th* 2 f/cm' sur.c.'C t ~ ^ ~ ' r\ i OUP 0907174 DU 028275 SU02 RtyitHf / Vol. 48, No, ni / FHdsy. Hovtmaer <, !9a3 / Ru|ci snd Rcyjijnon* snd sITon should be eontmuvd ie reduce ttbcttet dun ie low 1 level ts possible. Ai Din ime a u impussibie 10 tdi definitely (hat the standard td inadequate. becaust iti introduction n is recent. end it td et4Yu*i 10 follow up roups exposed to lowlivtli in order to improve tht ddtt ntcdoiry for the formulation of batttr smndarda* (Ex. M020. p. I). Finkddtoin (Ex. Id-Odd) ituditd the dovtlspatiat of compensable (certified) atbettotit tmoag 147 Onions aibestot coflioat production workoro in relation to cumulative exposures (f/ee-yoon). Ail worker* in tho study cohort had dt lout n ytiri of txpoture. Ontario cuana for eartifying stbattotis. whieh rdsuiia la tho award of disability pensions, srs not mftaxibls and involve eansidaration of lueh factors as history of occupational exposures. dyspnea, crepitations, elubbta* of finjtrt. rtdiofraphic signs of puimenary fibrosis, and abnormal luop function. Cartifieation of asbastosis haaca would occur at an advanced stags of disease. Each production worker was classified as having rseaivtd <M0. IMS. 100-149. 130-191 or 200-249 f/ee-yaars of cumulauva exposure withrn the II yeert fallowing initial exposure. Ftakelstain calcelatad incitlonce retts doaaiatira of number of now caste of artfied ssbostosis per too pcrsen-years et risk, (htcidenca la the rata at which new cases af asbesteais develop in a lives patted of lime. It it a direct measure ef the ntk ef developing tho disease.! Incidence rates were OJ. 1.4. ad 43 for warfctrs who received 0-40. 40-09. and lOIMlI f/cc-yeirt respectively. Finkaittein also calculated the cumulauva probability of having developed certified asbastssit by the and of 12 yean ef latency and observed that man ui tba (Ml. SMI. and 100-143 f/cc-ytirt categories had about 10 percent. IS percent, end no percent prrhsbilities respectively. Due te small numbers of man in each category, these estimated probabilities hod muds statistical uncertainty. Finhclttetn stated that the uncerteinun m exposure assignment* and the ttlection bill arising from exclusion from the stsdy of worker* with lam than 11 ytira ef employment ey have led to evareetimetion ef risk et low expetsm. which was to some extern balanced by the fact that the and point we studied wus certified disability, as advanced stupe of asbestos*' (Ex. $4-044. p. Ml). OSHA considers that FinLdstern's findings of excess nsk from low cumulative exposures ora very Important because the ouleumc. ccrtifiod asbestos*. was based upon lubstaniisl medical evidence of severe disability from the 1441-1447 Mortality wit observed during tho ponod 184i-in. Cumulative disease. Demint and collaaguca conducted a detailed study of plant processes end dust control mttheds si s chrysolite texuit plant during 1930-1171 (Ex. St ood. 14-417). Exposure hitu.'.tt wart constructed for each worker and tstimatas of individual cumulative exposures in terms of f/ee-days wort niidt. Altar IMO. exposure levels usually wsrt m the rings of 4-19 ffee. Workers ware eaiagortzad as receiving txposuras of (oss than 1000:100<MO.OOO: 10.000- 10.000: 40000-100.000: and greater than 100.000 f/ee-days. Sacsiua Demtnt it si. ineludsd holidays and weekends in thslr tsumatai ef f/cedays, their sstimetes of cumulative exposure art likely ta be eversuied. OSHA calculated that Otrnent at sL's categories of f/ee-d*yi are roughly equivalent to less than JJ; 2.7-27.4.27.*100.1.100.4-274. and greater than 27a (I cc-yaars of occupational exposure. expceurct. expressed ui millions of perticlit per eubie foot of eir toss years exposed (mpef-yoarsL were tstimated for each min included m the ttudy cohort. Mean exposures for I cumulative txpoaurt categories were 41 112.332. Ml and 171 mpef-yssn. Hammed at el. (Ex 44-277) suggested s mpef te f/oe coovirsion factor sf 1.1,4 for t cement plant, leesuse etoettt and ether miners! ptrtidts have bran extensively used In ssbsstes products manufacturing, using s conversion factor tf 1:1.4 doea not appear te be ^treasonable for Henderson and Enterlint's study cohort. Lisin; t factor of 1:14.12 mpcf-ytxrs is roughly equal to *7 f/cc-ytore. A respiratory cancer SMK ef iir.g was observed In the cumulative txpoaura category with a moan exposure of 42 mpef-yoars. Thus. OSHA views this study at having ebssrx'td exeats risk of dying from respiratory Nsw.--geciuao Danext tt al eauntsd eanear among man reiving cumulative heiideys end weekends for (heir calculations of i/eeteay* CCH., aivtUeC f/cc-4eye by MS to emve t eetiuuies ef t/ec-yean. oxpoaurtt permitted by the currant OSHA PEL Using t coovtrsios (actor of Id would result ie an estimate sf Damant at al.'s first 1 exposur* euraulativo txpoauri tor the low eatagonas fall within die range ef txpoaura tategory that it about Kft cumulative expoiore* permitted bylhe currant OSHA tbatiae standard. higher than that envisaged by the currant OSHA PEL. Among white melee with 11 or mere yean eflatancy. lung eanear SMR'i Dement at cL commented on the marked dlfTarenett betweonthe studies were 140.271. end 212 in the categories al Dement at aL and Hendarton and of lass then 1000.1000-10.000. end Enttrlina with regard to risk observed 10.000- 40.000 f/cc-dayi respectively.' from low cuatufativa exposures (Ex. M- The lettar 2 eaiagorits' axeassas ef lung . 037). Dement tt aL suggested that these cancer were statieticaUy significant. For diffaraneas may ba titnbutablt to tht other non-mtligntnt respiratory distaso (excluding both st'.iaua respiratory diseases and bronchitis), tho fallowing fact that Henderson and Entariint studied retiraaa 43 yters or older, with thee* rotlraai constituting s select {roup SMR't wort observed for white males of survivors. Only I of tht 33 lung with It or more years of lattney: 342 for eanear daathe observed by Dement tt el. man with lata than 1000 f/ce-dnyt. 44 for occurred is persons 44 er elder. men with 1300.10.000 f/ec-day*. and 171 McDonald. Liddell. Clbbs. Eytten. for men with 10.000~M.000 f/ee-days. end McDonald (Ex. 44-003) studied tht The sxcesses were statieticaUy mortality of 11.371 workers exposed to significant for both the first end third category'of cumulative oxposure. chrysolite mining and milling bom during 1491-1110. Mortality wet Dement et it. concluded: "tend on observed during tht pcnod 1110-1974. data from this ttudy. significantly elovottd mortality r.sha are predicted Each worker wet classified ss hiving accumulated less than 30.30-299. or 300 for lung cancer inti for ssbestosis at or mare mpef-yaars by sga 44. Using a cumulative exposures of ICO fibers/ conversion factor ef lJ for mpei to free eex years in the textile industry'' (Ex these groupings would correspond to $4-437. p. 413). OSHA considers that Demsnt tt el's lacs than SO. SO-SH. snd 400 or more (/ ee yesrs. Lung cancer SMR's were S3. ebttrvutiens uf excess nsk from luw HI ami 223 for tht 3 categories tuning cumulauva exposures are well- with lost than 30 mpef-) tars supported been... of the eertfui cstimaiiun of expusuro histones for tht respectively. SMR's (or pneumoconiosis were 2M. 10*1. end 4400 for eumuUiu e cohort. exposure calcgonct of less than 30 30- Henderson'tnd Enteriine (Ex. 44-041) 2*9. end 300 or more mpef-yeart I Irnce. studied the mortality of 1071 asbestos McDonald el at did not observe much production workers who retired during lung cancer nsk but did obserx n DUP 0907175 DU 028276 Fedtfal Rrg'.star / y0|. g N'a / Friday. NovemOer 4. naj / R.ncs arc increase in pneumoconiosis risk in in* law ttpaiura eetegon- A cssacontrol analysis usad umiiar yeen were lift. 20.1.1! J. ehil l.l for Croup* A. 8. and C end for Onuno men rrspecuvely. Approximate relative rises conditions and measured dull concentralions dgnnj that* simu.ii.cri in order io make mart accurate axposurt diagonal; however. the for Croups A. 8. and C it compand to rsiimaies of axpoiure during periods analysis wii intrinsically incapable s/ ' observing in ixcftt r4k m th* test thin JO mpefyaar eat*tory|e*c*ut* th* Ontario men. sra IJ. ItJ. and 14 for lung cancer mortality Gastrointestinal cancer mortality was tito alevutad la (pro-lKO in which exposures wr noi measured Mean eoncentrjnons of ' asbestos warn animated to mnge up io eonirol* bad ilia oeaiLehrysotil* miner* Croups 8 and C relative to Ontario men. SO f/ee before uso. and miliar*. Ragjrdmg the difTareni finding* on lung eancar nk from low ;o<iirn The lung cancer mortality rates did not consistently increase with"'' mertasing estimate* of cumulative Compared to Italian miles, the ovamll cohort had statiaticaUy significant axcassu of mortabiy from laryngeal between ihi studio* by McDonald it iL exposure m that Croup C had thi Iowan cancer, noa-malignant ratpirstory nd Oiatni it iU Domom n *J. lung cancar axeas*. FinkaUtam disease*, tuberculous. cardiovascular suggested imprecision of txpoturt iiiimitas ond difference* in iirbomo fiber characteristics * poonbli rtaiom lumsttd savaral potential explanations, including inaccuracy of axpoaur* classification*, statistical diseases. arrhoct* of th* livar. and accidents. Lung eancar mortality was alrvaiad only slightly (SMRwlOO): for the diffarancai. Ocmtnt end Him* fluctuations resulting from th* small sit* however, there was soma trend of previously hid found iboi textile of the cohorts and confounding affects ineraaiing lung cancar risk wun processing produced * hi|h*r proportion *f smoking if than war* diffaraneas in inertaaing length of follow.up. For of lari| thin fiber* filling within the smoking habiU tmong Croup* A. I. ind example, tha iSCR for lung cancar was ranges delintitcd u eirctnofonic by th* C. laeau** consistent dosa-raspoiua at during tm-irs. animal ttudio* of Stinton tod w*s abservad both for matothalioma Bfcaoaa all analyses of mortality in eoUttguts (Sit Station E(3) below. mortality and ubeitoaii in tha study relation to cumulative axposur* Eipttimontol Dotal. rinkeUtoin (Ex S*-30) olio nuditd mortality from lung unctr. mototheliomi. ind other diieisti among worker* ( in Onteno ubeitoo cement factory ettibliihed in 194*. The tudy cohort eonmied of 330 men hired before 1900 who hid boon cftipleyfd.it the factory for 0 ytm at mar*. Etch cohort member woe classified te hiving gdcumuiUtd MRTMJr. or 122-420 (I cc-yeor* of eebettoi axpocura within the 'll year* following initial exposure. Thou exposure categories. hirtiftir referred to u Croup* A. I. end C hid thi following mein cumulative txpoiuret respectively 44. 12. and 110 f/ ce-yetrt. Croupe A end 8 ere low exposure groups. Mortality by cumulative expoeure wi analyte-1 `'erting 28 yeir* after imttil expoiurc. so the' th* calender period during which death* were observed spanned 1441-ltW Cohort mortality wet compared to that of Ontario mm during tro-irt. Ag*'S`*dirdiied morulny nut per 1000 man-ytirt for specific causes of death were computed for Croupe A. 0. end C ind far Oauhe men Thus, this study did tot have the busts from eonfaund.ng effect! of ige that can occur when $MR`a aro being eamoared among differentgroup* of workers (See Ex. *-3k One puter.iul problem n that lung cancer mortality mev huve risen m Onittrio dunag i|7g> laid this would result in tom* underMttmauoa of comparison value* and hence aomo esemtanatwa of lung cancer rtik. I lowrver. than ovtrrttioutiuo of risk likely would be slight. Mesothelioma itMietality rate* |wr 1000 group. Finkolsttin suggested that th* exposure dasufieauona may have bacn com cl Fmkaluain concluded that luog eaecar mortality re its "may be raised *avaral* fold* (Ex. **-240. p. 143) at eutnulativa axpoaur** of 100 f/ee-ytart. With regard to gutrotntettinal cancar. Finkaiatam fudged that no fins conclusion* could be drawn due to th* mail number of deaths, although (hart war a trend of Ineraaiing risk with inertaaing cumulative axposur*. Masothalioma death rata* war# conaidrd by FinkaUtam to bo related to eumuiauv* axpoaur*. OSHA b*li*vai that FmkaUtttn'x study present* avtdanei of axet** lung, cancar and matsthalicma ntk from relatively low cumulative exposure*, namely 44 and 9' f/ee-yesrs. Lung career risk may <** bean somewhat undtrjtaitd by rinkelstetn's txeiutieh of lung canear d'ltht which oceurrad bafar* 28 year* of follow.up. Rubino. Pioletto. Nawhouae. Ssanxatti. Aresmi. and Murray (Ex. II OMf studied th* mortality of IU mat# Italian chrysolite minart and milter* during IMMITS. Mortality from respiratory disease and ither eauaas of death, but net from lung cancar. ai excessive m this cohort Crittna for incluiion us th* , ttady cohort w*ra survival until January 1.1844 and at katt en* month of employment during 1930-lthS Comparison of monaliiy was mud* to at*, calendar period, and causc-spucifie mortality rate* uf Italian males. In additioe. mortiility rate* ware compared among lh. cohort member* using a cast* cuntrul analysis and a historical pruapur.tire unulytit. The cumulative consisted of companion* among m* cohort siiBbert. rather than between th* venous exposure subgroups and Italian aula*, than analyses ware Ineaptbl# of dfitsiing axeas* nsk in th* lowest cumulative exposure category. The** tnalvete war* capable amy of dttacuag trend* (award incractad nak with ioercattd axposur*. Although tha axe**e lung cancer nskjodds ratio w2Jt) in th* high axposur* group was nor statistically signiflcanL Rubino at sL considered it 'likely dial iha Increasing aortalily truly reflect* th* affects of higher axposur*" (Ex. M-OM. f. 183). (Tha odd* ratio ia in aanmai* of th* reiotiva nsk dtGaad is die ratio of th* edds of dyin* from eancar m tha axpoted population to the odds of dj mg from eaneor in on unexposad popul*uoa.| Rubino at sl.'s study is unusual m noi finding a higher lung esnetr risk among workers exposed to relatively high level* ef ssbettos. OSHA beiitvts that th* trends of tncrttsing lung cinct: risk with both tnetssing length of follow-up tad ineraaiing axpeiurtr are eani.stent with in tsbastoa tuologj'. however. OSHA olio behaves that (ha hign rttks of mortshty from other cxutai such as non-malignant rtsptratory disrisa might have obscured lung cancar nak. ispocially tine* (hate high nsks appeared within the first it years following exposure and asbenes-rcl.iies lung cancar generally has lunger latency penod. Also. OS1 IA calculated that this study only had 33.3" power ;o dataet a W. incrcss* in lung c*nerr r j among weaker* with 28 or more ye." s of folluw-up. " mxn.ye.irs for Croup* A. II. and C wet* fiber exposure was estimated fur each N*4*.--4l1illuxl sower uugni>f"-l '* l.p. o and U.9 rmpoiitivfly. Urn: eaneri mortality rutvx (irr ItxO nun- worker m trrms uf f/cc-yrar*. The * imrxtijulurx suuuUivd puat working aluiiiy *{a study w dettei a tru* risk ) aprci(id axeruwii* and nrfurt <u > ou 0901176 028277 prebabili'y af net wiiiiae a true tux Snerail> i n csni.atrcs Sesirebie lar audits it ha* at itaat HA pewer. lacawaa hin| eanetr i a n-uutaljr cumn,tn cancer, tpieamieiorc I'udiaa mould 1m at laaat acr* p*"Vf la dtivet a Iffy increase la nab ef lung canear St* Ex. Iwv Car a daiCTpawft si CSI1A i r.aihod sf ealciAitmg powtr. Wtill. Hughes. and tAkgjsnspeek (Ex14-236! invaingitsd txpbsurt-mponsa rtistioftihipt between respiratory eanetr nik and exposure in an aaba<oa ctment plant. Waill at al did set observe excess nik among man with low cumulative exposures. A total of SMS ata with at laaat 20 yten of Isttney tine* Aral exposure in either of 2 aabtttoe eamant plants wart studied. Ail man had at laaat ant month of employment before 1P7Q and their vital atatua wai dtttmuntd at of Dsetaber si. 1*74. Each worker'! cumulative duet axpoaura during the a yeara from Initial exposure wai cmmated in terete of mpef-yttrt. Men were eiaitified in one of 5 different eumuiative exposure eatetonea: 10 or fewer. I1-S0. SI-100. 101-200. and U1 sr more mpef-yesrt. Using the eonvarnen factor of 1:1.6 sutiestad by Kanunad at aL the S cumulative axpoaura catetoritt wouId_ be equivalent to 14 er fewer. 1VTO, 71- 140. IH-2I0. and 211 or more f/ao-ytart. Respiratory cancer SMR's avert u .follows, starting with tha lowest category: 77.70.26.2*0i *nd 22B. Neat of the other eaeaet of death were in excess for worken m tho 3 lowatt categories. Concerning thair failure to delect exeaaa respiratory canear mortality in thetr lowest eats pries of exposure. Weill t: al. stated: "Such flndinis are sot nectar nly incompatible with t linear responat curv tt low data* becauia of tht relative insensitivity of currently used epidemiologic atthoda In detecting ali|ht tnereatM in risk whan compared to back pound. They do indicate, however, that any axcesa risks at low dtiiets of axpoaura are small" (Ex. 64-206. p. 3331- Weill at si. notad that tht relatively hi|h proportion (2Jk) ef the eohart who were lest to follow-up and ajiumad aiivt throu|h 1174 magkav* ltd to underestimation of respiratory aaetr nak. The upper hams ef tht MK confidence intervals af ths-fesptretory cancer SMR'a far the 3 lowest exposure categories rented Ire* about ill to ISO. indicating. in OSHA't apmian. that axeaat nak coaid not bo ruled cut for thetr categories. Berry and N'ewhoeat (Ex. 14-0211 ' atudivd mortality during 1*41-1*76 of a cohort of fnenen matenal production warktra whose exposures wets ^ mlativaly law Uvola of exposure ranted from ieia than 1 f/ce to t f/ee after 1131. end cumulative exposures for the cohort avvri|cd Was than SO f/ee- years. Although axeeaaive mortality from meaotheuoma was observed. Ultra -appeared to be little txetta mortality from lunp cancer. Mott of the mesothelioma eitat had been exposed to atbettot levels exeaedin| $ f/ec. Tht cumuiatlva txpoturtt to isbittot of the mesothelioma eatei ware sot reported by the author*. Unexpectedly (hit atudy observed xciitive mesothelioma mortality but only a non-tiemfieant excess of lung canear mortality. A titabit portion of the study cohort had a than follow-up panod between their initial exposure and tht atudy cut-off data. For example. 33K of the men bad follow-up periods of lets than 20 yean. Lon| eanetr nak may be expected to increase in this cohort at tha members are fallowed for t ionpar period. > Summery A number of tpidamiologie atudica have examined txposure-rttpenst relationships for etbtstoa and ttbettot-rtitttd diseases. OSHA r*eo|mxts that thara ere many inevitable uncinsir.au associated with tpidaaioiofie studiat af axpoaureresponse Rarefy, if avar. art perianal samples of asbestos enneamretiona (et axpotid workers during tha entire . period et exposure available. Invettiiatort typically have developed individual indicts of exposures from reconstructed occupational histories, reerm mduttnal hyptena data, and assumptions about past working conditions for which txposurss were not measured. Another question conctma tha faetora for conversion from histoneal matnods if meiaurinf dust concimrauons to currant methods of mtaxurtng fiber eencantratiena. Th* ratio ef millions of pameltt per eubie foot (mpef) to fibers b*r cubic centimeter (f/ec) hat bean suggested at ringing from id to 1.2. Conversion factor* ef Id for mpef: f/ce in cabeate* mining and milling and iri.e in asbestos production and asbestos eamant ooersuena sppesr reasonable to C5HA. OCHA tits recognises the statistical variation associated with estimation of Standardised Mortality Ratios ISMR's). loch ststittieil venation, ts well as difltrtncts in study design, statistical power, and length of follow-up. mey seesunt foe some of th* divergent findings sraeng studies. lecaust tht present OSHA PEL of 2II ec was effective in 1*7*. there ere few, if any. occupational eoher-s sxpesed solely to 2 f/ee or lese who have follow up intervals sufficient (or the appetrsnea of diseases related to tabesiet axpoau.-t, At prvtam. OSHA la not awurt of any rvidanct su|tgsiin| that mttntity el eipoiure will afTeei excess nsk in a manner difTerem from eumuletive tipeturt. whieh eneompesses both duration of exposure and intensity ef exposure. Most rpideimolofie studies have observed ' inoeasing risk with increasing cumulative txpoture. Ounuen el exposure may have an utdtpendtnt efTset on metothcJioma risk (see Section V. Quantitative Risk Analysis). A worker exposed to the OSHA PEL ef 2 f/ce for M yean would have a cumulative exposure ef 100 f/cc-yeart. Hence, studies of worken estimated to have reeoived dose to or lest than 100 (/ cc-ytan provide tvidane* concerning nsk from txposure to th* OSHA standard eve* thaugh tht psti lAttaaitist of txptturi aiy have exceeded 2 f/ce. OSHA considers that tht following studies hsva observed inerttiad ntx eioae to or baiow j00 f/ce-years. Berry et sL (Ex. 64-020) observed 11* prevalence of crepitations, possible ttbasiosia. end certified asbestosis it 27,41, and 63 f/ee-ystn respecuveiy among asbestos itxule workers. . Finktaieia (Ex. 16-044) observed a 10k probability of having certified ubettoe'ii among ssbastos emsnt production workers with cumulative exposures et lost than M f/ee-ysart who had been observed 22 yttn suie* their initial exposures. Ftnkslstim (Ex. ** 240) also obssrvtd excessive hing cancer mortality saeng workers with aversgs cumulative exposures of 44 tad t2 f/cc-yean. Among isbestot textile workers. Osmsnt et sL (I ' a-OJt) observed excessive aonaiity from lung eanetr tr.b non-maiignant rtspiratery disasaes et cumulative exposures of loss than iooo f/ee-days and 1OO&-10JOO f/cedtys (equivalent to leu than 2.7 tnd 2J-27.4 f/cc-yttrsl Hsndsrsoo and Enttrline (Ex. *4-04*1 observed tbout 2-fold increase in lung canear mortality among retired atbettot prediction workart receiving an avenge cumulative exposure of 62 mpef-ytars (equivalent to V f/ec-ytsrs using t conversion factor of 1:1.4). At relatively low cumulative exposures, th* following studies did not observe excess lung eanetr nsk or observed only e smell increase in lung eanetr risk. Berry end Newhouss (Ex. 14-021) observed Unit txetta lung cancer mortality among fnenon materia! production worken whose eumuiative exposures tveragid Isas then 50 f/ceytere. Mesothelioma esses were observed by Barry tnd Newhauae: j'j:? ! DUP 0907177 DU 028278 Fedorai Rei'jier < vji 43. \0 f rriuny ............... . .. ___ howevar '.heir eumuV'it exposures were not reported. Weill et 11. (Eu.. pa2U6I did not find incrtesed murtalny from any eause af death below 101 tnpef-ytsrt (equivalent to let f/ce yeart using a conversion {iftor af l.j <( in a cohort af asbsttot ealtent worker*. Rjbma tt al. (Ex. P4-4M1 cSserved only a slight sxeisi of lund cancer mortality (and a iargs excess of mortality front other esuses. luch a* nos-maliartant mpiretory disease) detpite hi|h exposure levels- Oats were not analyied by Rubins at ai in luch a way *a to permit estimation of rnk frost low cumulative exposures. UeDoaeld et al. (Ex. se-063) observed little or ns execs* leant cancer mortality eaeni aabeatea minerj and miliars reetivmg low cumulative exposure* Excess mortality from pnetintoeonieeii wai observed in thsdow exposure group, however. Worker! receiving (eae than 30 mpef-yesrs by age el had on SMX of 2M for pneuntocomaaii (30 mpd-yttr* rqueta 10 f/ee-yters using 1 caoventon factor of Wl As la commonly obatrved among epidemiologic atudies of etiologic agenta for disease, there art tome inconsistencies la the finding! of -- different studies of workers eseumulating relatively low exposure*. Statistical venation, differences in the six* distribution of suberne fibers. Imprecision ef exposure animates, end eoaastition imong different cxciu of death might explstn some of ths iaeensuttfteiu Nonetheless. OSHA considers that many wU.conducttd ttudits observed substantially incmaad risk ( death (ram lung canter and non* malignant respiratory dtstase among workers receiving oimulatwa sxposurts permut'd by th -urrem OSHA standard. OSHA concludes that these study results provide evidence of grave danger imm low cumulative exposure! to asbestos. C Corcinoftmcity ofAtbottoo for Sitet OUter Than U> Lurtf oad MeootMium 1. Introduction. A number of studies of asbestos workers have observed excesses of eanetr tt sum ether than the lung end mttoahelium. These sites include colon and rectum. esophagus, stomach, larynx, pharynx, buccal cavity, kidneys, and avert**. lasad an these studies. OSHA hat aasdaded that fsauoiatattiaa) araUtreaneni appear ta ave been predated by aatiestoa inhaled in ths workplace. tpidcmioluOTatedwabavejnyral.ng.ied tne eHrala tr iitgranen pfaabeaios m _ dnStutg water Cinaarudyjuagcited that eahetine m.drinking waljrr increused eanetr incidence in Sun Etincuco and OukLmd Ulanurek et ail wnile oifwr studiea did nut ooseryy a jrJutionship batwean asbeatot in -- drinking wuerand eanetr incidenca (Barrington at al.. Meigs et'al. Uvy tt el.) (Kang Ex. P4-1M) OSHA n awire that ecological studies generally have certain (imitation! for determining (he effects ef long-term environmental exposure to specific substances, including confounding variables such ti migration into end from communities and multiple exposures to other carcinogens and toxic chemicals.far example, inertssed cancer mortality in s particular community may result from , PCCUPaTlonal ramar man tram areinpge.ru uUhadniiking watery ambient air. Saciuitligdiff occupattonaTe0h0rta do oot.have as. many limitYtfons aa ecological atudies. occupational studita have ths potential to'ETSTbra ffttarminativt concerning _ eatmnogamc nik ta human*. depending ontixe of the cohort, length of. oFaervation of the cohort, and other pefTment factors: Tlmrafon. because* wall-conduetad epidemiologic studies of asbestos workers an available and bacauto inhalation rather thea Inissuer it tha primary rout* af workplace axpaaura. OSHA bat bssad its conclusions an tha potential caraaogsnicity of albastot tor litas ocher than tha lung and atasothaiiam an epidemiologic stadia* of asbestos worktit. t Sflidemieloty Studin. Baa* and Simpion studied tha mortality ol Selfait insulator* amplayed during 1M0. mostly ia shipyards (1171. it77) (Exhibits la- . 0*3 and 1*442). Vital tutu* was observed during tha period 1S40-II7S. Excess mortality was observed from Peeisti*. lung cancer, mesothelioma, and gastfomtasunal cancan (stomach, jejunum, pancreas, colon and rtetum). Elmos and S.-pson siattd that "both Is respiratory and in gaitrointtstmai cancan than ia tha difficulty af differentiating between masothaiial and epithelial tumour*'' (Du P*4t2. p. 171). Of tha iota 122 deaths ut this cohort tithtr autopsy information or clinical information with bioptias endfor radiographs supplemented tha death cartifieatat for all but 22 deaths. By 1HL is deaths had been coded at gastrointestinal cancers on death earttficatas. 12 of which continued ta be dsasified as gastrointestinal cancan aftar supplemsntal information bad been obtained. Using the exoectad value ef S.l deaths foe all non-rtspratey cancers that were reported by Elms* and Simpson. OSHA calculated that the gustroiniritinal cancer excoai was statistically significant at tha 0.0S level (oM-Wiied Poteaoft trai). Cm** *nd Simpson esnetudeti ,r ;Mit 1071 pupert "Cancer ef th lung and stcsotheiiomas do not account (or ail exease of deaths: a significant etcest of other eanetr* remain... and mast of these appear to be in the gestremiewinji ireet" (Ex. M-oai. p si. in tnetr trr paper. Ernes and Simpson reported a dseiine in both asbcstosia and gistrouittsiinai cancer ai maior causes of mortality among iht survivors followed from tgcr-itrs. Selikoff. Hammond, and $c<dmsn studied a cohort of 17.100 US. and Canadian insulation workers [Ex. Pi- 000). Companion of insulators mortality during 1M7-I*7f was made to age and calendar penad-ipeeifie mortality rani 0/ U.5. white male*. The large sue of this cohort retailed In very high statistical power to detect increased mortality from spacific causes. Thtrtfon. OSHA considers that this itudy tames much weight with regard to tha question of aabtstea-tnducad malignances. The Invttogiisrs sought supplemental eJinteal. surgical and autopsy information In order to determine tha extent of miaciassifieatien af cancers. Band on death certifiesta information alone, significant txccat mortally was observed from lung eancor (SMB sop), mesothelioma (104 deaths), esophageal cancer (SMX 213). stomach cancer (SMB 12*1. colon-rectal eanetr (SMB 1S2). laryngeal eanetr (SMB-mi pharyngeai and buccal eavtty eanetr (SMB-1111. kidney eanetr (SMK223l aU ether can cars (SMR-m). and non-mfaetiaus retpiretety dtseaaaa (SMR-llSI. including 71 datths from asbestos.s. With ths axeeption ef dsathi listed as 'all other eanc'*i". redssufieation of dtiths based on supplemental clinical autopsy, snd surgical data resulted in slightly highar SMB's for ths causat of datth listed above. OSHA beliovsi that Salikoff at il.'i reeJaasifieatioa of causes of death is justifiable boeausa mtadiagncsis of masothelioma and asbettosn can occur duo to that* conditions' reier.tilanct t: more common diseases. Furthermore, it ia posttblt that matasusas from prurcry lung c*nears could be misdiagnosed as primary uncart of other sues, and 1 ice- versa. One disadvantage of reclassification of dtaths. how ever, is that tha extant of miaclassifieation w the comparison population of U S white malra remain* unknown Nonetheless OSHA believes that, for this parneuUr ceheet. the advantage of reef.issifiei 'Cfl in term* ef improving tha eeremty about the causes of death sutcy"s < 'e dtaadvantage- : :" ' 4 DUP 0907178 DU 028279 S117B Federal Rtomcr / Vnl a*. \o 2'.i ! F"d:iy November 4 ngy / pu|e, 3.4 p,.,,),,..... in the category luted as *sll tiher eonuri." 232 (Jtaths were obitmd unpini la IJ1 * deaths expected. The excess in this titulary . mostly due (o irtertatad mertelity fm panereiue uncer (SMX2SI|. Iivilsnd biliary inet unetr tS.MR263fpro*t*t* cancer (SMB 1171. ndV*m unetr (SMR 1*3! VVhcn recltsufied according to supplements! in/ormstion. th* ptncratuc unur txe**s tselmed greatly tad th* liver and biliary tract cancer exeesi dusppesred. Selikofl Hammond ind Sctdraati concluded; "Aibuto* uuuUiMa worker* ta th* Untttd Sum tad Ctnidt suffer in txtraordiflsry isaetud nk ol death */ unetr ind etbuiou* tiipeititd with their employment Thit mcludu inert! mi in dttth from luji| unetr. piturti mesothelioma. pentane*! mesetheliotnt. ctaetr of th* *toptat|vi*. ealan tnd rectum, uactr of iht larynx. tro* phsrynx. Kidney. tnd pirhipt ttomich. Son* iaerttMi weft itia in unur of several other tittt. it well. hut date tr* Inadequate tt thit ttm* ta petnit charaeteruation of tfciir signtfiunu. tlthough ttttntian It calltd to tuch wider inert**** (Lx tM>3a 114). Oamam tnd colleguu !E*- **HH7) oljsecved itttittiuily eeo-eigmfiunt lncrtete mdigejUv* unetr marltlity `(SMRwtJl). WhenDerntMeteL eanflnad that* entireit to whit* malt* with Uteney miervule of IS or koto yean ind examined rrpo*u.t-reipcni* relationthipt for digestive system eanear. SMR't ineeistd with inert*tin* cumulative exposure. rangai| up to 190. Baoauu of th* tmtll numbtrt of deaths, eon* of th* netitn af digestive unetr In tny cf th* expo* c*tt|on*t wr* statistically ngmflcint. McDonald and eeJ'eagve* (E*. *4-0*$) obtarvtd some uterttttt (nat statistically significant) in mortality (ram esophageal tnd ttomteh unetr tnd from eolo-rtcttl einur tmont chrytoni* mintr* and miliars in Quebec. Cttiratntettinii unc*' SMR'e merttud with httvter umulativo exposures. Sttdmtn. Saiikalf. tnd Hmamond (Ex. *4-0*7) ttudttd t cohort af *20 amotit* intuit (ion production werkers imploytd tl t Ntw |*rt*y plant dunn| 1*0-1*41. A ttatittiutty nca-sttnifitam emcass of ftitroinlttunal uMtr (etaphagut. ttomteh.' tnd ooianrsetum) wat observed (SMR 1211 Henderson and Enlirlino (Ex. 14-044) studied th* mortality during 1P41-1V73 of 194* retired aibestee factory worker*. Fiftyfive death* from digestive tytttm unetr wtie observed compered to 3** death* expound ISMR* 137J| (OSIIA , calculated that thi* excess w . tuitittically significant at the 0.03 level. uimf t one-tiiled Potsten tattl. Nicholson. SeitWo-'f. Satdman. ind Hammond lEx 44-1J1) tlto Itud.'ld I cohort of U S iibcttat fictory worker* tnd aPtem ed i itatteoully nonugnif.etnt t S-foId txeeie of gtstroin:tin*l unetr Ntwhout* ind Serry (Ex. *4-3301 oburvid * gastrointestinal uneir SMR of 134 In * canon of London atbtitet factory workir* 160 dtith* aburvad vtrswi 44.2 xpactid) (OSHA uleulattd thtt thi* unit w* t'ttlttiully *i|mfic*nt it th* OOS Irvtl using * oa*-(il*d Poiiien tut). Puntoni it *1. (Ex. M-2461 Kudiid th* morttlity of ihtpyird workir* exposed to itbittoi in Cano*. Italy. Thru worken were tUo expeud to ether tout tubittne**. taeludmg illlu. beniene. eerben tetrachloride. tnd polycyclic tromitic bydrourbon*. Compand to th* i|t-ep*eific merulity rittt of malt Canoant. the shipyard warktn hid etatiitietUy significant inereiiti in morttlity (rent colon eanear (relative rltkwl J1|. All of th* itudiat line* ui thit paragraph t'-o obtarvtd axutitv* mortality from lung unear. In addition, other mvaytigator* hav* abterved exettiei of diiattiva eynra unetr. Robinson at aL (Rx. *4-042) abtCAtd to SMR for dlgtativo tyitem unetr of 121 (not atatiaticaily iigfltfiunt ixeaii) antaag iibtitta preduebon workara. Klautfold *1 ai (t*. *4-140. 4-t4i) obtarvtd an SMR of 400 titatnucally r.gnifietnt) for digattivo lytttm unetr among traatoltt* and aathephv'.lit* ixpetid workara mining Ulc. Mancuso and Couittr (Ex. 14-224) alia abearva* a significantly elevated digiitiv* lyetem eanear SMR among insulation workara. Kinktlittfn obeervtd a tratuaully nor ngnifiunt 2-foid Incraaia in mortality from digattiv* tyitim cancer emong esbettot cement werkers (Ex. *4-L<0|; A number af ttudia* have not bttrvtd txeauiva gottrointattiaal etneiT mortality among workan expoted tc etbaiut. Ntcholtoo. Selikofl. Seidmin.'Ulii. aod Parnby (Ex. *4-072). who etudtad the mortality of S44 chrytanla minor* and milter* from Quebec, oluofvcd * g*troint*attnal uncer ShtR of only 10S. Weill. Hugh**. od Wiggerupack (Ex. *4-200). who ttudttd t cohort of 3 *43 iibutoi cement production workan. eltt did not oburv* *n exuti of death* from gtttromnttma! uncar. Other iavMttgeioni who did not obterv* *n ino*s in gtsuotniutinui cancer merulity uieludt Berry tnd Newhout* (fricben matenale pnduction workere). Rubino et *1. (chrysolite mmen). Meurmtn at tai. (amhaphyliita mintr*). Drown et ai. (ttie worker* e*po*(d ta tibtstat). Went (chrysoitia fuctary workan). MeOoneid nd SfcOon.ild (eitxitoi (1*1 milk wore art). Pt'.e et il. |*ibt*te uxtil* worker*l, Thcmaj ti : (uoettai ument workenl. Reime* ind Cole* (ihipytrd werxtn|. end (one* if" al. (ubettoi gu mask worker*) (Ex *4- 2J6|. When nen-gisiroiRiesilntl uneers it iita* ether th*o th* lung tnd mtiothelima *n eon*tdnd. *t Itttt 4 ituditt obirvd xc*si(* tt then other itti: Selikofl et al. Shctiigara and Morgan. Puntoni it al. and Still and McCiD Othtr iiudiai have not observed excesMS *f unun tt othtr tit**. On* iuu which th* Agency had to addnsi wit hew to weigh the penult epidimioiogic data .ersut th* nonpotitlv* tpidemtolagic dttt. On* eontidendon I* steuttlctl power, th* ability ta dtttct * out nik tf tuch * risk exist*. Th* Chrome Hiurd Advisory Panel on Asbestos (CHAPI convened by th* U.S. Contumtr Product Safety Commission did not find * eotuiiiir.t nlstionshtp b*twetn kivutg a higher degree of statistical power and finding xuuivt mortality from thatt othar eajtcan (Ex. *4-236) tt should b ootid that tit* study that hid th* highest ttslittiuJ power by virtue of studying 17.400 warktn. atmtly thtt tf SaJtkofT tt tl. *kirvsd txuiHt af gutrouittituitL ltryngitl Udaey. tad phiryngttl tad buccal uvity exnctr. Another consideration is th* nUtienthip between th* magnitude of txui* lung unur ruk and execti g*ilrointasun*l unur nsk. CHAP observed thet itudiet with high lung unur exceesei were also Lkeiy to nave found gaitfointtattnal unur excetsci. Because high lung uncer neke would be expaettd to hav* resulted from relotively high expoiurn. this observation lupgtsts that tiitromiesuosl unur excuses ire round wh*n txpesums art grtiir. which fitenut* th* plausibility af (her* being * true association between ttbestoe *nd gtsuomtestinei uaeer. to smnmary. at lean 12 different occupettonal cohorts exposed ta isbesioe have been observed ta hive ekttSMS if martalitv from gxstroimreunel unetr. 7 af which were statistically itgmfiunt OSHA eenudert (hit the** finding* eonttitut* mbinniul tvtdtnu for an *t*oct*tion between ilbatta* ixpcsure and gastrointestinal unur nth. The evidence for e relationship between esbestes exposure end unur it ether sttti it netewor'hy yet not ss substantial as that regarding gattroiniMtmal unetr. Ccldlirmh (Lx. 4^2331 reviewed the evidenu fur uusti relationship between esbuKis exposure tnd non- r c " -> c DUP 0907179 DU 028280 Ftdlfll Hetistcr / Vol. 48. S'e. ns / Fridy. November 4, / Rules *nd Regulations JJ'.O" pulmonary esneer us I studies ef 11 occupational cohorts followed foe at liui 20 years unco initici exposure Ho concluded that the data 'east doubt oa whgthar thort la site-apeoficity of libesics-rtiattd ufcar* and that 'a systemic carcinootfie reia ta atora likely [for aabattoal" (Ex. h4-Oi pp. J44-J47|. l Touee/ofy Siuditt^iuabuai tonedopjladies hayg.oaen conduced ta aotamina tha uretnogsmetty of_ tSgtstad ubottei. Inhaled aabaatoi a. &po$hl.lo tnttr the digestive tract Ktfh asbestos fibers ctught.in ^t* ituopue_ T^qg of tha' lun* art broughtjip toje "^raai-aadjuailawad. Alio. Hbori t cau|ht in tha nog may travti down to "Wo pharynx [Kane. Ex. SVT3SV Zvatu at *3. (Ex 14-238) conducted an inhalation study tn rata of radi>labeiJad croddolitt. 2>a radio-labelled... . cjoadditi traveled to the loryatc . 'esophagus. and |aatrotateajuiaJ tract jaasadiately after exposure. and area largely aacratad ta the facta within tha X days following inhalation. the National Toxicology Trogram (VTTPias administered ehryaottJa. . amcaitaTtramolit*. and crocidolita is . Toed (1% of diet) to laboratory animal*. Tocreated incidences of tumors baa* net Than reported In any a( the NTT stvdtaa {Exhibita U-221 $4-27$, $4-227. *421). ta aomwof tha studies. relatively ahort Chon were admbuaiertd. Tha ubaatoa doaa of 1* ta diet waa not tho maximally tclaratad doaa (MTD). unlike seat carcin#|fieaia btoaaaaya. Ward. Frank. Weak. Davor, and Tarona (Ex. ia-200) -"'"< tha affect Choral txpoatua textr.osite or chrysetifa jnjasuoiataitutal (Cl) ureinogsnssi* jiaona FM4 rata who bad Oats taiaetad entb ixoxymt!h.me. Azoxymtthana ta a well.reeogmiad intestinal earetaoita for Iaborutory ituaali. Kata wart clao exposed to amoaita aioat and axoxymethsns atone. Tha axpoaurt parted waa 10 weeisi and tha rata ware tbttrvtd lor <S weeks or mart (iocm rata did not stsrnve oa long oa U week*). Alihoath awootto and chryaattla rxooture'ifid notj'tniticianilysweats ^ tfia incidence ofCfelncsfatos| ratal fiveh'aroxyatathana usjornnaa. aha i% rtia raceivint amouie aksto hod an m unusually high madanullt*.) ofeaMt^ Tgcinoma cuinsured to the Tneidtnu among hiatorical control FJ44 mi* ~" -miaiuitsed ta tho um Ubontuty.' * War! at ai. rtfaeted an (h*-s* ftndinnB "Tito sasuU* of three experiments sums** tint oral aabotioa eepa^fY may kata CattanisStAPtllsd tnculrnet of tnleatiral inniur* in male PPM rata .. AltlKswik uuriwdmgndid at cuaclniively drmunairatc thr.cn. . C4*Eiauiii"iie or carnnutrnie rffwt of axittltos fur thr intestinal tract our results suggest >ha< additional stniitlvt aKfmal rapanmanta ara naroed' (E*. **-:aa a- ittk Boltin. Davit, and Umb (Ex. 14-714) admimattrad tmotitt. crocdolitt. and chrysolite m diet aupplamann to Wiatar rata for parsoda of up to IS months. Malignant turnon. including Cl tumors, ware sot increased fa tha eabestoaexposed animals compered to tha control* however, chrjiotile-trested rets bad a statistically significant axeass of bantgn tumor*. Tho axcaaa of benign turnon ta ehrysotlls-trtatod rata wu largely due to an excess of mesenteric hemangiomas. Belton at si. thought that tha observed exessa of benign lumen in ehrysotilftrcated inunali was not likely ta be due ta aaboatoa because they did net observe asbestos fiben in the mesentersc lymphatic daauaa of tho animals. OonhdtL Barg. WRL and Uinfngsr (Ex. M-J32I fad FJ44 rata a diet consisting of 1M shrysetile. A total of II* aabaatoa-ftd rau end JU control rata wart studied. Regarding their findings. Denham at al stated: `Although th" rsskdifforaneaa far development of colon tumon apacifieaUy is set statistically significant at tha 5% IsveL wa feel there la auggtativa avidtnee that ingested asbestos may have soma role in salon carclaagtncsis.. .* fix. $4-232. p. 10*0). Smith. Hubert. Sobak Tatars, and Doarflar fx $Mit3) admtnistand amoeite asbestos In drinking water to Syrian hamsten ef tha Lak: IVC strata for periods ranging up to 22 months. There was sems cluaiartng ot malignaat tumors, including a pontonssl maaotheUema. a pulmonary carcinoma, and 2 iquam u n tall carcinomas of tha fortsiomieh. in tho hamtttrt axposad to amesite (4 ef 110 animala) Nona of iha control animals drrtloptd thoaa types of malignant tumors. Smith at al. did not consider tha dastsnng of maiignont tumors la aoumts-txposed aatmals to bo ralstod to their tngtsiian ofamoaita bacaasa><hea types ef tumon have bean sbsanrad to control Syrian hatnttars af the Lak: LVC strain by other iaveattgaiart. Q<HA coaitdan that jhara la asmr - andpnc* that oral mgiatioh'oT Wbaitfit. to earmhugenie' ta laboratory animals: kawtvar. this avnjJgjssTs'jistTisr iheaasistant, af non.jostttya.lyTfstudias _is somawhtt Timitad by Iha lowJotaspnilhshJihdfS that won admuustarad ta the animals. 4 Summar*. la sumnury. at least 12 tpidcmioioute studiua have observed inertused mortality (rum lsirointrstiniil cancers among workers expos'd to aahestoa. 7 of which wart itaiinteally aigntficant. Also, at tauat 4 (pidcmiolnttc (tudiat hava ahsmtd tteissn af canear at iiitt e:n*r ir.n tha raaptratory tract masothelium. nd gastraintestmal tract. A number of oir-- itudtM hava sat obiemd inotstes m mortality from sancirs at ittct ether than tha lung and mesothriiua. It ta possible fee physicians to misdiagnose pantonesJ mesothelioma sa gastrointestinal er othtr cancarc however, tha axctsi of gsitroutieturul unear pantatad svan after Dmai and Simpson and SallkofTat ai radautfiad cause* of death using luppiamental autopsy, largieal. and clinical Information. OSHA baliavts trial tha rtsuits af these neisistfiutioas constitute additional mdenu* fur an usacistioa between asbestos txposure nd davtlopmsM af itstromtasnnal eaacar. OSHA ngards tha numerous epidemiologic studies indicating tnauasad risk from gasrotnitstioal unear si ourwaighing son-positive epidemiologic studies snd non-positive and aqtuvocoi findings in snraals Inlasting asbasto*. Dma-rasponsa ralstionihlpi for issmintMtinal eanctr sra eharaetsnaad l*u wall than (or respiratory system eaaetr*. ` NonsthslMi OSHA cotieludas that gattyeiniasUrul maUgitancis should be includad ta quanntstiva ans lysis of txcoss unear tiak bom asbastoa exposure because such cancers hava nude substantial contributions to the taoeased mortality af many cohorts of ssbutos workers. Otherwise, excess uncar risk from ssbattos axpoaurt weuid be understated. Tha excelsea af maiignaneies at sites other than tha lung, mtsoththum. and laatrointsstmai tract absmad by SalikofI at iL art pardeulsrly noteworthy bauusa of the large sits cf Saiikoff at el's eohort. Tha Urge sics of their cohort resulted in a high degret of ttatiattul power and a high tltgrce of subility for the observed SMK's OSH A consider* that asbtstes might indues unear at situ* other than the lung moMlhulium. and isitreinttstmtl true based on tho studiss fmdir.t esnesr sxessset at thes* ether sites, esptcial'.v iha study of Saiikoff t aL OS) IA will not attempt to quantify the excess r.ix as these other anas in ralation to exposure. OSHA view* trio ev idenrr fa* asbestos tadudng gaatromtastinxl trust unear a* stronger and mor* coni'new than th* avidanu far aabastos inuuim; eancar at thcia ether sues. D. Cffrctt of C/yarvite Sr.ivkii'X 1. fntnitluciion. A muitipiir.iiiic cffri: of asbestos expusure and cisurwtc smoking with regard to prouuctns iT DUP 0907180 DU 028281 Sll^a Federal Retlihter / Vul. *A S'p j*j / Friday. S'qi cnL><r 4. >art3 / Rulra ,imj R'-uu.'jtir;n* me:t*ed luna eancar ruk wxi ihowa in ;W4 puptr by SeiiWoff. Churg. and Hammond (Ex 2-i). Subsequently. ether studies of oecupetionei cohort* confirmed thi* finding (Selikoff. Seidman. imJ Hammong Ei *4.1*0: Hammond. Selikoff. inJSeidmen. Ex. from lung canear ihai wot 5 time* higher thn th.n of non-emuking cnniruli. The lung cancer mortality of imolinq iihenoi worker* wee alia S lim** higitrr ihun 'ha eontron w ith a hmory of eigurcne imoxiAg. Thai, for bruit muting und noft'tnvAirtg ttbetto* woraur*. the relative nu of dealt! Ircm lun* eaneer wt sltout s-fold Hcner. me reuunnahip between ciMreite mmurj and esbeeiot expoture can ben be t de*enl>d at mullipliealive m nature M-OS7). Cohan at at IEi *4-031] otierved poorer particle clearance from retie i tht Iua|> of laokcra than from the lungs of nen-asoktn. Thu finding may haip id 4g*>Stn*er*wtt kimg Cancer Out* ttui explain the higher lung cancer ruk of smoking aebetioi warier*, le addition, 1/ tea*tog ittiai wo Cceuotttenel smoking asbestos wortore have been reported to he at higher nak of Ntlttry Of Xitel It* (tattVM atbeatotli and eheat X-rey ubnormsiitia*. including pleunl plaque* UO**r *i*ur/ tf (Hammond el tl.. Ex. M-047; Went. Ex. *4-0*7; Weiae. Levin and Goodman. Ex. U CigartU* team mrum* *-"--) i Th*r it **" *v<i**'>~ * ia aiioditionTttwetn.ctjara.tt* iqifkuip `rreua kibttmT* tewing? *(* Oiffiwci nu **t~nd either neiothelienu nak tr XJJtraiatutiatl cancer nak (Hammond Control* m ' so 11.3 0.0 l.uO at . Ex. *4-047). X. Aftpmtcry Cancan Hammond tf i. (Ex. 04-047) collected smoking ilMItll art art Tft a* U.4 47.1 (.17 hi*ten** from 0220 of tht 12001 insulation worker* with a follows* par.od of 20 or mote year* tinea uutial Ciotran fat lU.t 1114 10, hi txpeeure who hod bees itudied by -- SolikofT and colleague*. Tht monolity txptntnet of then worker* wo* Nrtirt r fat 001.* 5M4 U.24 ' obtorvod during 11*7-117*. Of the 1220 .workan who answered the qudtsionnout on iraoktng habit* tn late IN*. (Ml war* etthar eurreni or pott rest* r*r 100.S00 wx-uart (taatartuM for ago oa (no inti ioukoo ef tao aon-je*r* of all tn* tsaotco* aoreart (Kite an taat* eanifijita tnfareatttai fra* Rmnon* ( t<., (a. 04 0*7 eijaretta smokers. 4*0 bod * history of pipe or cijor imokinj. end Ml hod ntvor mokad regularly. Tha cemponaon population waa drawn {ram tka Amenean Cancer Soeietyi lang.term proapactlva ap<demiola|te study conducted by voluntrar*. and canaiatad of 73.783 white man who hod no more than o High ichool education, were not firc.tr*. were alive at of January 1. 1907. and had a hmary of occupational exposure to dual. fumt*. vapor*, gaso*. chemicals, tr radiation. The motor tdvtntat* of this eoaptnson population wot tht availability of egospecific mortality ratti by imokm* tiaiue. Alio, men with tha ebon dvtcnbod education and occupation*!., hfttonca likely would reoomblt iha insulation worker* mere than dm general U.S. white malt popuiiuon. AgS'iundoiditad lung haacer reonalily rein (or comma tad far eelieete* worker* are gives ia TabI* V At ahown ia Table I. aon-imakmg aaiwsto* woriore bad * maeulny rat* Regarding ihu* data. Iha S'JOSH/ OSHA Ajbeitot Work Croup stated: T> Ht`nr effect ef inmUn* and tibeotor axpottao tppoan w be now then anal* addition If tht combined afreet wort additive, on* rauJd tipoct death raitt tf 1M.7 per too OOB Bjiwyttit tmong eiaottnt werteri >li tmoked. Thie rai* wee derived (ram the tun. of the koiolitc nit (ltd) pluo the rum over mot Odtetme duo to tabootoo (S4.*-!1JM| plu mo txttlt duo to eawkmg lia*-lU llUl Thedou item rather t* tonify t muttipiicativt model It woe ikew* that eatokiag tlono incretwd the death rite hbext 11 Uaei and aiboiioo lion* ncreoatd It i nan. Therefore. roe o mliiolictuvt modoL ihd mwtaluy rant (be Ihoeo rvptMd la Item iibeitet end imaking woM ba U (I time* It) umot giotier ihaa those who were expeeed nenhor ia einoiiee ir tp looking. The monatny ratio lor moot oxpatod to iibtuao end to eigorattci wot tctuolly IU4* (ta. a*-m p. ri SolikofT. Seidman. and Hammond examined the effects of eigoraito imaking end aiUeiio* axpeturo among M3 amoitie production workers. S87 of whom had smoking htttonto (Ex. 041SO). As in Hammond at tl ' study, companion wai mad* ta tgt and causeipocifle mortality raitt within each tmokmg italu* caiatory of tht Amertean Canetr Socttty (ACS) cohort. Non* imaking amoeitt workere had a greater ihen 5-fold mereait in lung cancer nek compared to non-imoktm m the ACS cohort while imeking oaotut worktre hod tn almool Hold ineratt* compared to thair smoking ACS counterparts. Qaiad on the ticota lung cancer nik m non-smoker*. Solikoff tt el. stated that asbestos exposure alone produced tn inenaoed risk tf lung canetr. although tha increase among non-imoker* was limited in term* ef total number* ef additional death*. For cigtrettt smoking tiliettoo worktre. Solikoff tt *1. described the incmted nuatbon of lung concur deaths at "deveststing * Solikoff ei *1. observed no inereeied risk of danth (ram meaothelioma. '. * - DUP 0907181 DU 028282 rtwc>i Awt>.c< c-ivirutniunsiinjl eaneer. and >j*bv*iosi* mm* smueine amowite wu/kert k 'irf.rvd lu aunsnioking'.imoaiic worker*. 3 Urf/ Qiteeu and Oeit X-ray I -'ttlrmuhtiet. Hammond at ai. reported m.'i jibvS'0i* worhlrt who smoked u<# nr more pocks oKijarette* per day r.id us ssbcatoa moebslity rate 24 urn** h'^hi-r than lhat of tebcatoe worker* n nu had never smoked regularly (Ex. *4-0*71. Hammond *4 el alia repened dial as-iaioktrt wno were atbciiot worker* hid lubeiemtally fewer death relee dun eibeeioe worker* who had not quit amoaing. Wein (Ex M-007) conducted e cheet X-ray and questionnaire lurvey at >00 eebettat textile worker*. Wetei reported that imoking worker* had a 409 prevalence at pulmonary fibrosis and nen-tmokmg worker* had a lt'< prevalence at pulmonary fibroin. A (radiant in riak of libretti wai obietvad for both increasing age and inoreeiio* duration of exposure. The a** diitrlbutioo* at the iraoker* and non- imokar* war* simitar. ai were the median durationa of txpoeure to aibaito*. Weia* concluded that both aibaato* exposure and cigarette -- smoking war* atsociated with ppimoniry fibresi* and that aatokiitt ' atbeitoewvorkar* had a higher ' pravaJince of fibroaia reiativa to non smoking aibetloi worker*. Weil* did set indieatt whether the difference in pulaoaary ftbmia prevalence between antoker* and non* imokan waa atauitieally significant. OSHA tailed the $t|ntficanca of tha difference in provtlenca of pulmonary fibroin between tmoktr* and non* tmokert aaing a eht'iquared tan of proportion* and did not futd a stpiificant dtirartnc* (p greater than 0.X). In 3M1. Wtiax levin, and Coodnun (Ex *4-09*) reperttd th* reiulU at a lurvey of 41 ran aged 40 or more who had workad > or more yean in an aabeatot manufacturing plant. 7he prevalence of pleural pluouet waa greater m cigarette intakee* however, there was aome capfounding of this relationahip by eusnalaliv* asbvtto* expeeur*. which aian leemad to influence tha prevalence of pleural plaque*. Wetaa at al stated: -CaacteaoM aee msradwd hv tk* man niuoUs tf worker* at tiua mv*vnfiio A c)v*>euf tu ih# ***iu &> m$oruutm i^vfctrti i ktli nttanit tffun. ttuu`i7xiaw * tan *v **4 * **ucH * c^huft X-nti uppi-ursne* of puiffion.trv ftbros.s nor cuniriiHiii*d to f.hrosis rasuittnu frem ssbu-MOk npoxure. In summary, mere u some evidence lhal smuling aiuesios workers have Pearie |Ei 14-071) surveyed 1.11 hi*hcf rial of montiitv from aatv-stgsu. asbestos-exposed shipvurd workers to * wi-ll as higher prrvalencr ul determine tne relative eomnlmiion ol crepitation* lung function decrements itbtt'ot eapeiure and inching to lung end smali radiological dpacilias. This function deertmenii and chug* X-ray evidence is mconeiusiva. Inomaliijci. IVarle found that both eigarto* imoking and aibestea axpoiura reduced FEV1 (forced expiratory volume in 1 stwnii) and KVC (forced vital capacity), with combined exposure having a "Cumulative or possibly lynargiitie elTeet ' (Ex. 14-07*. p. 3k). Pee'rie elec reported that both smoking and aibeatoi exposure produetd pleural and inttnntial abnermalititi and that imoking appeared to bo th* primary factor in airwova obstruction ond diffusion impairment. tarry. GiUon. Holm**, lewinaohn. and Roach (Ex (4-030) itudiad >7* man 4, Atlnbuliny Probed!* Ctiolvyirt h< tuny Cunctt Among Individual Atbetta* tt'oriem Enierlme (Ex. *4- >20) enabled ihe probabilitv that nv imgle rasa cf lung cancer in e person with known exposure to ssbesius could be attributed la th* itbastns exposure His paper emphssised that ii cannot be aisled with eartamty that * lung cancer in an individual worker was dut to aabastas ttposurm rather, tttitmentt con only be mad* concerning probabthtiit ai eausa and effect. Hr convened observed relative nsk> into firobtbUitiei using tha following omuia: employed at an **b**tot textile mill as of |una 30.3SOI. Smoking hutort** war* available for 37* men. Men were classified aa having ntver imokad. a* at Mg ( *! ex-smokers, or rs currant imokor* (light, medium. or heavy agarttlo . eopdo-*..., .f o m consumption}. The moan cumulative exposures (fibars/eubtc eenumater* yean) ware similar among th* imoking itatui group*, and age adiimment* war* mad* to account for tha youngar agaa of ooo-smoker*. Significantly graatar Using Selikoff at al. s data on prevalences of cetpttations and amoQ radiological opaettiti were observed in heavy smokara and tx imoxire compared to non-smokers and light amoken. for axampta. 189 of htovy insulators, whtr* s rtlttivt risk of about 44 was obssreed for smoking asbestos worker* and non-smoking isbtstas worker* tiikx Entirhnt tsiiir.attd a probability at lit that lung canears tmoktr* employed after 1130 had small radiological opacities comp* red to <A* of navar-smokars employed after 1950. Kdbum (Ex **7137) hat reviewed th* studies e' th* relationship between cigarette smoking and X-ray evidence of pulmonary fibrosis. Kilbum criticised Want ! use of a definition for war* attnbutabl* to atbostot evpotu/e for both smoking snd non-tmok.np asbestos w-orfcars (3.3/44 v. too is abcui 0.7S). Enitrlutt's papar is important in axpionngtha txitnt to which asbestos out be csasidtrtd th* anologie agent for pulmonary fibroaia othar than that of th* t'lng cancar in txposad workers, 110 in hit 1*71 nudy. i* well ea th* riowaver. us tha com at smoxing small number of workers reperttd on in asbrstot workart. dichotomising Weiss's 1*71 paper and hit other papers. eauaatiun at either dut ta amoxing or A study by Samct ct tl. which Included , da* td tsbtftds don oat team a relatively large number et lubiecta appropriate to OSitA. beeaust of the end which did not find an effect at factor of syoerytsm between cigarette cigarette smoking on radiologic smoke and ssbtstot. Using SclikofT ci abnormalities characteristic of sL's dotx probabilities at causeiioj, asbostosit was etted. Kilbum concluded wero emmoteii by OSHA for each that eignrattt smoking neither produced eliokigic factor (Sc* Tablas t and 7) DUP 0907182 7' 8 DU 028283 Smo Federal gutter / Vol. 41, No. JiJ / Fidy. November < iq03 / Rujel md Rej,,ia;:on, T 40l 6 1^5 CAACEH "CRTAUTY it smoking status^ lung Cmcer tste be* 100,000 oar Yesr Swting Agbottai IntwlAbort: 242.0 ken-SOktng AibtStOi InguUtorg: <0.* Smoking u.S. Kates: 74.4 flon-Smefcing u.S. Kales f.2 i/Fraa Solikoff t tl.t 1171'(E*. 14-010) Tool* 7 FERCEKT ATTRIluTAaiE RISK FRO* ASIEST0S EXFCSURE AN0 SMOKING tun) Cgnctr Risk Attrtsutiolt To: oekground AiPtstot 4lent Smoking (lent Inunction of Smoking end Asoos tot Fomsli 9.2 . 40.4 . f.2* 31.2 74.4 - I.2 8S.2 362 9.2 21.2 - 4S.2 266-A 1 AttriguUfllt (ttk for As&cstos worktrs: Smoking kon.Smoking 2.SR 22.85 S.fiS 77.25 18.01 70.85 TOE 'IWI While OSHA s stipulations differ from EaierliM'e ulcuiotians of otinbutoblo risk by usetuding tha synorgioni factor. ilia probability catinatn da aat differ much. According to OSMA'i caloriclice*. asbesios exposure cootribous ta Tt4t and Tfj% at lung caaetr daatba amon( smoking asbestos warkara and un-smoking eebaataa warkara respectively. 4 L Summary. OS) LA considers that aIbefine exposure by Iteclf eun eause Hint cancer, aabeitoaia. mneothirflomo. and gsstrotmcttitul mlisn.inJCf. tktraby presenting a significant health rak ta exposed workers and a grave doncor undsr current exposure cenditiona. Cigarette smoking by itself as eause lung disease and lung eanesr. Cgimtc smoke and asbestos exposure appear to have a multiplicative relationship tar causation at long cancer. Msnulity '"m ssbestoeis hue been reported ta be increased in csga'Otte-xmnking asbestos workers eump.in-d to nun*Hitching asliestos wuriirs. olthnugh this tvidence is iaconr.Usuvt. Piuural ptnques and tha radiologic Ibnomsiititi chsnctrr'stic of pulmonary fibrosis have seta brrn reported to be mart prevslrnt m cigarette-smoking libcstos workers. :hn evidence is slso inconclusive tv , smnking asbestos workers hsve been reported to have decrened lung esneer nik relative te smoking siestas workers There is no svtdsnea for any relation ship betwein cigarette smoking end Induction of mesotheliomas end gastrointestinal malignancies. Ae/ef/tv Careineftmeity and Tanicity afOiffannt Ftbart 1. Introduction. OSKA has reviewed tha data concerning the releuve carcinogenicity end toxicity of different asbestos fiber types and hti deeded not te make distinctions in this emergency temporary standard by ssbostes fiber type with regard to regulatory provisions designed to protect workers from the harmful affects of tsbestes oxpeture. Mainly, this is becausi lung concor is tho leodiag cause of death associated with asbestoe exposure and there do not appear to be differentials m lung eanesr risk by fibtr type. Some Investigators end eeramstteet hive suggested that different fiber types of osbtttos hove difference* is their carcinogenic potency, including Enterline oad Henderson (Ex. .40-124). McDonald tad McOoneld (Ex.' 44-184). Weill t< aL (Ex. 44-284|. Aeheson end Cerdner (Em. 44-01] end 44-243). Muir (Ex. 44-JSO). and the Advisory Committee on Asbestos (Ex- 4*-JiS). These scicnuate tenerslly believe ihat erocidolile end amenta are more cartinotenic than chrysolite ind tnthophyilile. lesed on thee* scientists' recommendations, both me United Kingdom md the province of Ontario. Canada hove promulgated the following standnrds for asbestos: U fibers per cubic centimeter (0.2 f/cc) for ooeidolito S.S fibers per eubic centimeter (0.5 f/cc| for amesite 1 fiber per eubic eentimetcr (1 f/cc) for chrysolite <! *U other forms of > asbestoe Recently, the United Kingdom hoe anuunced reductions in the limits far chrysolite end tmosite. it is ur.portsnl to note that the question of differentials in potency by fiber type primarily concerns induction of astsoihcliomss. not asbcstosi* and hmg cancer. For metoihcliome. Aeheson snd Curvlner m 107P described * powerful earn ` ihnt ameidoiite hus been more dangefuus than chr> soule snd ihthuphylUle'* (Ex. e*-:i4. p 1U whuruiis they duractcntcd evtdrncr fur DUP 0907183 DU 028284 fiber 'yp kitlecmilieli in nek from lunf cancer ina itbetions at "inconclusive* snd 'iligM" reipcetireiy (Ex. *4-21* p. width is J.l or frts'tr. Evidenet for nik from fibors .ass ihaa S |Uti in length te taeoneluiive. Ill- A snticsl eneiytie of the evidence In 11*2. Aeheson and Gardner stated: eonesrrting nsk differentials by fiber 'Peritonea: mtsotheiioms hai an almost type end fiber dimension follows. txelusivr relationship exposure 19 the amphibolta erocidofit and ameaiie' 2. Esidtmiolo$te Oats--introduction: Commsrosl ssbesios fiber types (Ex t*-M. p I). Coaemaing lua| including smosite. ehiysoule. and cancer, they noted that Although one eocidoliti. have been observed to bo study (Weill at al. Ex. 44-206) had found associated with elevated risks of a higher rlik tnenf workers exposed to ibestosis. lung cancer, end eroodoiilt. no *daar diitlneaon" of rtak mtsothtiiome whether exposures by fiber type could be found when the occurred to a single fiber typo or to alopet ad dose-response eurvet were venous combinations of fiber types compered. Hence, they ceneludad that (NIOSH/OSHA. 1H0. Ex. *0.320). availablt evidence did not auppori the Excess lung esnetr risk snd ssbeststle itiumption that chryeenle wee a ieei have been observid in enihophyUite potent lun| earanogen (Ex. *4-243. p. I|. asbestos workers; however, bo eases of In 1963. the Chronic Hazard Advisory mesotheliomt have been reported Pent! on Asbestos (CHAP) coaveoed by among snthophyllite workers. the U.S. Coaeumar Product Safety For emssite. tn association between Commission else reviewed the evidence exposure end disease has been for fiber type diiTsrtntith ia observed by the following Inveetigetort: etranogsnie nik (Ex. *4-234). They Seidmaa si el. IEx *4-0(7). Anderson t concluded that there were incentittMt (L [Ex *4-017). end Murphy *L (Ex end meondusive finding* with regard to 0411). For ehrytoule. the following lung cancer differentials by fiber type. Investigators have oblainod positive For pemonesl mesothelioma. CHAP (ladings' McOosiold et tL (Ex. 14-0*1). condudtd that tpidtmiolegie studies McOoneJd sad Fry (Ex. UiCOll LuddsQ suggested that this disease was most et el (Ex *44S0) Nicholson et el. (Ex eomrnea In eeieeite workers, test 44-072) ftubiao et el (Ex *4-0*0). commoe in creddslit* workin end rare Dement el el (Ex 10437). end Achaean or noo-txsteni in chryutilt workers. end Gardner (Ex *4413). For Evtdsnet fir s fiber type differential in crocidoiitt. positive findings were pleural ittsothtlioms nsk area not observed by the fallswiaglnveetigeten: considered by CHAP te be at losteo 01 el. (Ex *4-13*1. Hobbs el el subsuotiel es for peritoneal (Ex (0-132) and McDonald sad mesothtiiome. McDonald (Ex. 14-1*4). Mauraan et tL Soma health sdenuits who believe (Ex M-ilij observed ia excess lung that evidence links eroeidoius expoture cxacer nsk among onthephyllito suaers U a aubatentisl iaerette in mesotbeiioms nak have suggested in Finland. ta addition, aumeroiss studies keve observed isbettoeie. lung eepente nguletory treeunent for esacer. sad mesothelioma emoag craeido' 'Ex. *4-n*|. OSHA kaa been workers expose' a mused fiber types urgtd to consider requiring that workers (Hughes sad Weul Ex *4-133; WeiU et exposed ta eroadoiitt or ssbtstos L Ex *4-234. [oats et iL Ex *4-13* mixtures containing erocidolilt wear Berry et el. Ex --420. Elmes end appropriate respirators, irrespective of Simpson. Ex *440. Peto et sL It *C suborns concentrations al ssbtstos and Lacquet et si. Ex *4-144: Sslikeff et ai_ irmpecties of compliance with the Ex e ana. Rebinson et al. Ex louw; penr'istblt exposure liatii Furthermore. end Belseige-Mont* sad Segsrre. Ex 14- OSHA has been urged to consider 011) AJse. severs! studies of tele miners reouinng that emploreee rxpoeed 10 end millers, when the talc contained oocidubtt be informed of the peieatiei tremeiite an- taihophyUite. ksve greeter mbs assecieted with crocidoiitt * observed excesses of lung eencer and and the reasons foefhqaimg respirator luag disease, and reductions in usage whenever croedulam expoeures pulmonary (unction (Kletnfcld et el. Ex occur. OSHA invitee comments on this *4-140 (4-141: Brown et al. Ex *442*: suggestion end on other ahenutive 'Cimble et aU Ex. *4-1*1). In addition approaches to upturn regulatory unlit*. an asbeatifora mmirel found ia treatment ofcremdeliie. tka toil end water in two nllagoe in There ate also etientifie questions Turkey, may bo responsible fur those concerning the reixlionship between vtlUgee high mortality rates from fiber dimension* and ability te causf mesothelioma (Artviali end Buna. Ex. disease. OSI IA believes that asbestos 4441* Burls It al. Ex M-110|. fibers longer than i mieremeters (nm| OSI IA is not twin u( any cause lung disease and cancer, provided epidceuologie studies which compere that ihe ratio of (ibuf length la filter .workers exposed to different fiber sixes wiihm the nme irduiiriil precen L'ndeubiediy. ihn it due to me loreiiy of such oecupeiionei groups since reu occupstionsl popultiions hive been exposed to e mixiure of long snd ihort fibers. Therefore, aoit of the due on differential risk by fiber use ire from ' experimental studies rsilver then epidemiologic studies snd wdl be discussed la section (UJ(3) Ltpormsntel Data. Evaluating the rtfetive eardnotemeity of the different isbettoi fiber types involves eempaneoa of results ham different epidemiologic studies. OSHA believes that it ie important to note the potential difficulties of comparing different occupational echorte. Standardized Mortality Ratios (SMR'sj are nek meaaurti that era dependent an the age disoibuuoa (es well as other factors) of the particular study population. This it btceuti the vilucs used for comparison, referred to is the expected values, ere derived from mortality retee spoafic for ego. nee. sex end calender period ia tat comparison population. Cancer risk rises with iacnsiuig sge. so that an older population would have higher expected veiuet foe cancer mortality. Misleading results may be obtained when compering risk measures for cancer emoag study populations with different underlying ego dietnbutieax A* example of the eusleading resuite that may bo obtained in such ea instance ie gives ia Ex *4-231 which Illustrates that SMRs of diverts study populations may bo tht seme while the actual excess nek of mortality may vary greatly become ef differences in ege distribution. Sox snd calendar period of observation aiso effect expected values, because women have lower mortality rs.es from lung eencer end lung cancer be* risen grestiy since the iWi Length of foUow.up is another pivotal variable because of tho long latency periods naeaesary tor development ei lung cancer sod especially mesotheliomt. Epidsmioiefie Studios of Lunp Canetf. Mstethslioms. and Abtsttosit: Tho following studies examined the question of differential lung esnetr .nsk by asbestos fiber type by comparing the mortality experiences of different occupational cohorts: McDonald and McDonald I Ex *4-134). Henderson snd Eattrlme (Ex. *4-0411 Weill et el. (Ex 4-20*1 MeOontid end Fry (Ex 64-004) and Achates et el. (Ex *441J). Some of theta studies also addressed tht question at differential atsoihtiiomi ritk by fiber type. Some additional studies 0/ workers exposed 101 single fiber typo ere also pertinent to evaluation of nsk by fiber type. DUP 0907184 j::72c DU 028285 inciudm* McDonald t l. fEx. M-OSSV Hebbl (t iL lEx. M-13J), v. mi itx. 44. tt*|. Oiment ( ti. (Et. *4-0371 and Berry and .Stwheuit (Ex. U-4M). McDonald tnd McDonald (Ex. *4-tS4' lu{fttttd Sat crotidoiil* wii nor earcmoftme San ehrytotila baaed an tit if eompxnton #fthl mortality of Canadian ehryiotiJ* itinera tnd silltri with that of Canadian Wtrktn einufctunn| croeidolitt-cenitininf (it milk*. Far ( auk worktre. 13* ad 16% af tht obaemd dtaSi wtrt ban Itrai cxnctr md maaeSeliema r**p*cavly, (a contrail. t% ind 0-26% of tht abaarved dttthi intent shrjneitii ouiin and nulJif* war* from lunf eanetr and fftiethtliomt reipectivaly. Om patttnal probla* wi that tht penanr.al tteardi af tht eocideliti workirj wtrt incomplete. which eonId mult in biciti tewird obtervtn* pittar or Itattr nik in Util cshert An anpubtiahad rtpert by Or. Hia K. Kanf (Ex. 94-11*1 commuted it fellow* aa thii oompenaon: (1| Two tiiiar potential eon/ouadirty factor*. Sbtr atat diatnbu&os aid fiber concentretioot wtrt net mityiid by tht tathari. If tht ( esaak plant* bad hither fiber concentration* and/er a hi|htr proportion of lent thia fiber* than the mine*, a hifhtr cancer riak would be expected in the plant*. ' (1} Companion at Hah mtanrta inch u Standardized Mortality Ratio* (SMR't) tad Proportion*!* Mortality Ratio* (PMR'a) taifhl net be tptrapriatt between the two occupational cohort* becaoia of potential difference* to ( diitrtbuoon and len|th of follow-up period. Headcreoa and Enteriin* (Ex. *4-04*) oampartd monthly of retired worfctt* expottd to different eibeatae fiber type*. Ai.er edjutnnt for difference* in cumulative duat txpeturt*. Ktndtnsm and Entarilna reported tha followwj raiptritery lyittm etneer SMR'a for workert ia aa atbtttoa factory and workara aanufactwint aibeitta etaant: 247 far weekart resetvui* chryiaul* txpoieret only. 344 far weriara rteeivinj amoaitt export/** only, and 491 foe workert rtetivutf combined axpoiurt* to chrytoltit tad eroddolitt. Aibeito* cement pipe worker* bad very hick fane caacar SMR of 521 Header*#* and Eattriiae itated: "Men who woekod la the production ot aebootoo camcm pipe exhibited hither tick d reepiiatery ceacer. aa did men with aem* eroddolitt eibetio* expo*ore. Becaate the** tw* (loop* overlap, w* eouid not be certain that craeidoUt* tabaatoa waa retponitbl* far the taaoeaed nek' (Ex. ht'Oak t Concerning Htndtrion and Efttarima'i findinfi. CSHA natta that the ubeiio* cement ptpt axpoiurt* may hjve been dujtiir Sen eertier etttmatea indicated no that tome af tha workara theu|ht to have been ixpastd only to chrytattia may hart had indirect expoturt to eoeidobte. Alio, worker* tn th* ubenoi ctment pipe operetion probably were upoaed meetly to ehrytoult (Ktrtf. Ex. 94-133). Another potential eon/oundiof factor wai that expoturt levela were unetrteia for iieh (roup if worker*. Weill. Mu|h*a. and Wa(|tnapacfc (Ex. 94-3061 itudni tha morulity af aabeata* camant pipe work are in two plant*. In the firxt plant worker* were expated to bath eroeidolit* (3% at product | tnd chryaotJ*. In ths aacoad plant worker* wire txpoitd to chryiotilo. amettu (1% at product), and eoddolitt (iafroquaatly). Weill it at ropertfd reapiratory lyitim eanear SMR'* a* follow* for worker* rtetlvfnf cumulative aibeito* txpeturee peater than 200 million Pamela* par cubic foot-month* (mpefmonth*) during th* first 20 ytan of taploymne Hemoidaiitt expoewe [atemuttcni ixpoiuro la tread* tit*......................... .........CMP ur Sutdy wqpoeero to Meddtliit--_5MRa*4l OSHA not** that tho apparent differentia in lunf canetr n*k by fib*r type obterved by Weill tt *L are baitd on roiatlvoly imall numbar* of death*. Hanco. (uuatie*! venation may be coniidered poetibl* expltaatiea for the ebterved difference*. It (a not known If the 75% follow-up rote may bavt contributed to ti. i* apparent difference*. WailL Zlakjnd. W*n*n*piek. end Reenter (Ex. 90-U7) luoeated that croedolit* exposed worker* bad poorer pultataary hmettim than worker* txpoitd ta ether foreu at ttbeetos. They reported that oddallta worker* bad mailer hint volume*. a hifhtr prevalent* of X-ray ehan|*t. lower FEVl'i. and reduced diifuilnt eapadty. Neli^nvt refer* to the volame tt tir ftrmMy exii/id t* *n* neend. and dJiiuva* aepawy eeten ta th* akUily if exyyin w letvi me itMoti in* emir (hi palneMfy Weedeaeim. Redvcuva* ia FEVi aa* difhttaf uyey art iadtMUvt W Unpaired luafhnmit*. . A campartaon between Canadian ehryeattle mintrt ituditd by McDonald at al. (Ex. *4-065) and Auatralian ooctdolitt smart ttudiad by Hebba at aL (Ex. 14-132) ha# beta nude by Kant (Ex. *4>t3*V Th* Auttrallan minen with one or son yev' of rmploymmi and 4i UiH If yetn of follow-up ttod .ur* cancer SMR that mu approunm y twice bi|h at that ef Quibtc nnen with one or more yetrt of implo) n*ni and at ltaat 20 yean of follow-up Csrapanaea ef thata two (roup* of r miniii it probltmatic becauit af potanuai diffarenex* s a|t duinhution. fiber uaetatretioa*. tnd lentth of employment (Xafl*. Ex. 9^135). Ackteoa Cerdner. Pfppard. aad Crime (Ex. 94-011) ituditd mortality of (imila woiktra maaufactuhaf msttiy chryaotile^oauuinc |i* maaka in one plant (Plant 1) dunnf lUt aad ftmala workara auaufaetuftaf awetiy eroeidolit#-ecnuimaj (it meika and acmt cbmotita-coniauuat tu matkt in a aaeoad plant uj US* (Plant 3k Plant 2 kad a laiftr txcata of mortality than Plant 1. A|tt at Initial ampleymtot wort vary aimilar at tha 2 planta. At Plant i. 7 !uaf cancer dtatha ware tbtarvtd venue 44 expected (SMR> 145. itatiaUcaUy aoa-ttfnificant). One dtath from plauni saMtktiicm* waa obtarvtd ta a faault werktr ires Plant 1. At Plant 2. IS hiac cancer dtatha were obitrved vtreua 4-2 axptcted (SMR-241. p lot* SOI). Maactbtlioma waa sentioned on I weaea a death eartifieate*. 3 of which coded aetotheiios* u the todariyiaf caaae af dtath. A autUtieally aigtifieaai (acnai* la avariaa cancer mortality waa also obatrvad at Plant 2 (12 dtath* obitrved vtmt 4.4 expeettd. SMR-276. p leu than OOl). Poaaibly. St death* e*rtlStd a* dut to ovartaa cane*r may have actually bean eitaelatmXlad perttoattl metothelioma*. Acbtaoa at aL concluded Set "the pattern ef mo--.ty ia coaaiatest with Sa view Sat maaoStlioma (and poaaibly avtnan canetr) i* paroeulariy luodated wtS expoiurt to eecidolitt' (EX. *4-016 p. *47). Aeheeea tt *l.'i atudy haa 2 advantaiti nlatirt to eSer ituditt of population* axpoaad to diffartfit ubaatoa fiber type*; boS S* i|* diatrtbutiaa* end ien|tha of follow-up were aiaular fat Plant 1 and Plant 2. NiHhar as eoeeaantton* nor durttioni of tmploymtnt wtrt teportad for St 2 planta. however. Becauae Plant 1 had Men operatiai lonter than Plant l. Plant 2 worker* may have had a irtttir aadian lanfh af eapleymtnt. Manual anufacrunnf procaaiea wan ampioytd at Plant 2. whllt mechanical proctaata were employed at Plant l. Perhap* St Manual proeea* led u higher dual rxpaiure* (or Se individual workan it Plant 2 Yat 11 ia alto peaaible Sat Sa eiachanieal proctat at Plant l reduetd J DUP 0907185 XJX] 028286 Ftdctal Rttitltf / Vol. 48. No. n$ / Fndv. Novenucr < -.^u KUICV '.hr ditmttar* at ihr fiber*. rtndtnng Lhtm sort kixardou*. OSHA eoruidtr* ihel thil study provtdts sugpasuv* tvidtnee (or fiber type differential la mesothelioma not however. thta mitnet it set eondiiijft because of tht lick of information ft the eir eortctntritwne and dur^ion* of employmoat ` Both pleats kid excess** ol lung eencer mortality. although only th* Pitot 2 Item* trot tittitlietUy i*nificiaL OSHA aUalattd that tht statistical power ta detact i iO% Inertas* (a lung eencer risk wee oaiy 1W it Plant 1. Given tht law power to dtttet increased risk it PUnt L OSHA belitvea tht itaUibcaliy aon-significant txctu of lung eaaatr it Plant 1 should not bo dierteerdad. Alio. AehtMa it iL calculated l confidence tntervela for luni eaaetr mortality u 131-3*7 for Plant 2 tad >MI for Plant 1. In OSHA'i ritw, thtit overlapping coofidtaca Intervele fat tha 2 plaata indicatt that tht obearvtd difiamcta la hint eaaear mortality eannot bt eoniidtfad auuitiuUy difTaraat Hanea. OSHA coneludtt that Achaaaa at ti-'l atudy dott oat ttubliah tht txiittnea of a differential ta Iuni eaaear rtak by fijar tyu* In thita 2 ocrayitfanii cohort*. Wtiaa (Ea. M-9W) studied a cohort of 1M traduction woektn In paptr and millboard laetory. ThU factory bad uitd oaiy chryaatfla aaboatoo. No Increased mortality from lun| eaaear waa obtamd imoot thtaa wttkara (4 lua| cancer daatha observed venue tJ2 expected). Two ran diad if abaatoaia. OSHA noted limitation* of Wataaa ttwdy that include lack of oibaatoo expotun data aad vry low atatiatieal power. C 5HA e ' "ilatad that thi inady had only 14 prwar to dotaet a SO% (nemti in lung eanear flak. Hanea. OSHA doaa not consider Wataa a atudy it reliable andante of low eaneor nah iwon* chryiotilt wtrkirt. Demmt tt il fix. M-0J7) observed a bi|h lun| einear flak among ehryaottla taxtila wotkara (U daotha t&atrvtd varaut 1M0 expected. SMXolil). A high nik of moetclity from non- aolifaint moratory disease*, including cabectoeia. wu tlto ohaaiwad In thii cohort (21 daaihs abcarvad v*r**s IS] txptctad. SMA2P4). Ona porttaaaai meiothtllfa waa coahrmed by tutopty. Sararal other death oBtifieataa Uatad **oacar ad tha abdomen.* hat tha aalhata won wsabio ta abtiia iddhkomi data ta determine whether thaoa particular cancan wara actually aseMthrliomit. Expected- valuta lot moneltiy wara dtrtvad from U.S. mortality nice. OcmcRt at aL luuaatad thaw tht higher ruk af raiptratoiy eaaear mortality m ihotr ehrytatilt ttooitd worker* tnploytd 1-4 >tin It pt4u A. eohan compared to cohort! of chrywtdt 9 and C reip>r*tory tyttim eeneir aman and adltra may have bean Out SMA'i wart 22i. 149. and ti to diffarem fiber lilt diitnbuiione. reapaeuvaly. Among mala worker* Uaiag txpeeied vtluia of lung cineer mpioyed 20 or more ytar* at Ptanti A. mortality dtnvad front the Soutn B. and C raaptratory i> turn cencer Carolmt uuaty In which (he chryiotilt SMK i warn 212. Ill and 140 lexute punt wu lecaitd. uutttd of U S. rttptcuvtly. The iowtr ratotritery mortality ram. would have rtduetd tht ceneer ruk in me* ta Plant C wu lung cancer SMAa lot tht cohort uiitxptctod. givaa tht btghtr air beeauat lung cinctr aorttiiiy ram coneantrationi ta Plaat C. wtra 71* higher m iht county thee in A diOtreat petttra at r**pintory tha Wattad Statta at a whola. Oemant at lyaitm eanear nek wta apparent for af. cosiidtrtd a af tha county rataa to famtla workera eomperad ta mala be Inappropnst* beeouie of tha worktrx however, the ftmalt rertelity probebl* eootrtbutien of a naarby ihipyard at wall u tha itudy plant to rataa ware not ttabla btceuae af tha mall number af daatha. Ftmalt worker* (he tftvettd iun| cancer ratal in the oouary. Stett (Souih Ceroline) momltty ram from lung linear ware ainuier to in Pltatt A. 8. end C bed raipiraiory tyittai cancer SMA'a of 234. Ml. and 32 rtapactivoiy. then of tht Uni tad Suit*. Dtmtat tt ti alto addraiitd tha poaiibility of eonfouadini affeeta from tmekinj. Quaitionniim adminlattred bi 1M4 and ltn to workara aaploytd at tha plant did not indicate that tha irndy cohort hod a ki|htr pravaiaaea af ireakin| cespued ta tha U.S. peeulatian. OSHA rtjirdt Oamant at al'i atudy u troo| avidiBea af tha poianoal for high lung eanear ruk front expotitra < ehryaoula. McDonald end fry (tx. IW)S) puhfukad t preliatnary report on their entdy of 2 ubeitec fcetartac fPUnu A cad l| where chryiotilt waa uaed aidaaivaly tad 1 factory (Plant CJ where chryiotilt. totoiiit. and ooeidolitt were uitd. Plant A wet tha atudy plant rtpertad on by Oemant and aeilaegun. Pleat C had pravtoeaiy been afudiad by Robutaon and eotlaaguaa. Rtapiretory lyitrm ceneer mortality waa in axcati at ell ] pUnu. Cxpeetad value* for aach plant were derived from the i|t. tax. tnd uuet-ipecfie Mtulity rataa aitha itataa ta which tha piaau were located. SMR'a were ealeulatad begiruung 20 yean t/ur initial eaiplaymtat et the piaau. Ait eancaatrtb tt were highest la Plaat C aaat ta kigheet in Plant A. and lawaat la Plant 1. Cnttna tor ineluatoo in tha ttedy eahotu wen: (1| One month or more of employment by Jinuery t. tfia. McDonald end fry ehereetarutd iht dlffarancM In tha diatnbution of maeothalioma daatha among tha ] plants u "atrtklng.' Plant A bad 2 death from maaotheliome (wO.5% of tU daatha] and Plant had so daatha frtat matothalioma. Plaat C had II daatha hem metethelieme (1JS% of all death*). Pauably. aa tvta gmattr aushar of daotha from metothtiloma oceumed at Plant C due to ouecogniud caata bung codtd at abdominal cancer* or other/ uupadflad caacin. Robiaaon at ai.flh.MMM2) had alio tbaarvad a high maaeahalioma ruk among wotkari at PUnt C McDonald and fry cooaidtred the probability of miaung true cuai of maaothaiioma at Ptanti A aod to bo lew beeaue of good esoeor eeao aaeanatnaant in the treu when thtat pteau wart locattd. McDonald end Fry ateted that axpoaurt- ruponae teletlooahipe et tha 2 plentt might ba eJarifir' after tha individual tebfecte were cieieiJltd by txpoaure laveia. OSHA eaniidan tha following potnti impertem for inurpratiag the finding* of McDonald tnd Fry. Although McDonald and Fry itrabhed by durattoa of axpotur* for their lator-plaat eamtrioo of King eanear mortality, other important vanablot war* not eontfoUed for. jndudlttg age at initial employment, fiber concentration, and and (21 having iny Soaai Security ' langth of foUawflip. Plant C which had AdnuniitreUon ftltt. Vital itctuc wet the grtatcat manbor of daath* from determined ca of December 51.1(77. maaothaiioma. alto bed tha highatt The evtriil retptratory tytttm eanear axpatw* lovaie. Kane*. OSHA IMP wu 2U at Plant A. confirming tha ooneidert that tbf difTtranoeli in high huy cancer tick abcervtd at tha camt plant by Dcaunt and eoUacguM. furthermore. McDonald and fry noted meaothaiiomt flak among tha 2 plant* art auggeabva. but do oot coneluitvtly demon*trait iacraaaad miaathcUoma that thetr laduiioa of eltneal warktra tad weaken with t-l montha of axpeaure In the cohort, unlike Dement et oL probably raduead oburved raepmttory cancer rut Among aula ruk from ereodofiio ralativa to othar ubcatoe fiber tyou. Of intaraat u tha finding *f higher hmg cencer nk tt tha chryaotila pteau (A and 81 rtittiv* to pleat C A|ut. the vcrieblai of fiber DUP 0907136 DU 028287 out* rr*3e'i *<"imr ; vot I. No. its / Friday. Noterw^ Vatu Mttrijnii t *j,,. * . cai\cvr"rtion. a|* dttu.iiuiiQn. and leiVh af follow.** naad to be controlled for when computing lung canter ntk. of different cohort*. worker*. Hence. Ct l.VT ennudered that evtoenee for a differential at tung uncar rtik w a* eviied and inconclusive I Ex. M-1SOI. dvtncted bocauxe af the oi.cMxUtn.n Mi.t eli control* h*d lo h*v* puimnnt-v mctjitaie* Coitrotnieitinal eareer* omatime* metaint.je |0 if., Jerry and NewheuM (Ex. 14-02!) and PaiMauy Studmc Wupner. Bern1, lumc ituditt huve observed etcettry rf Vew haute. Jerry. iftASlidmore |i. U- 1UI ituilm the morialiv 0/ a cohort 0/ workers minu/aetunoj fnciion xinnali. Exposure was to chrysolite lieluinsly. esctpt during U2V1I33 and lBh-1944 whan a amall pvretattgt ef tha work/area ii exposed to eroodaiiie. Ajbeiis* ixpoauret won low la the plane only i\ of the mala workers aeevouland aa rsueh a* 100 f/ cc-yttn. Tha only eaiuo of death ia and Putilay |Ex- **-*ttl examined the aiuena* contcmi of tuaue .imples af lung* of itbeitoe testil* worker* who died from metotheltoma end other eeuitt. Wagner at af. did not find either higher ehrysoula or higher craeidolitt eontcata in tha lungs of tha OMtothalioma eaita camparad ta the lung* of iibeetai worker* who died from other eautee. MeOunald, McDonald, and Paoity geriromicstirul eanctr among aibriio* * arxar*. Second, unc* chryiotile conautuies up to *01 of eommeretJly used eebeetoe and unce eabestoe exposure is ebiquitout. one would txpect wotrail 10 hav* eJirysetile fiber* In thair longs. The ttidttprtad *xpo*ure (0 chryaotli* could obaeure a true relationship batwatn enryaotil* and atiofhelianit. axecai waa mtioiheliom*. To eutaine (Ex. go>i7S| conducted a study af the McDonald at tl. luggtated that etiologie factor* for aieiothabomo. 0 raiehad sate-uniral atudy waa mineral fiber content* of tuna tfoett for chrysettlt may bt dexred fa 1 tar from M outopatod metothaiioma u*t and H tha lunge than other uoestei fibers so conducted far 10 mttothtlieao cam. autopticd uotrota. Contrail matched far that ehrytotil* reteaitan in tha lungs Far each care 4 contrala ware teieeted from the plane Control* war* ratchtd aa year af bira at tha factory, lax. age. and duration of amploymaae Qafiant croeidolita axpoaurt waa diacovarod In tha occupational hiatona* for I of the 10 mtiotheliome cate* and for 1 of the 40 control*. About KflS of tha saae* aad mx and age ware (attend for each meiaiheliome mm. All contrail had been diegnsied aa having pufmtnary matoatiMt from a primary cancer other then lung cancer. Umg tlaaue ipecimnu ware examined for minarol fiber content using an tltctron miacratcopa and X-rey anargy-diapanivo tna!,t*r. may not be the beat way to utimatt chryiotile exaoiurs. RowUod*. Cibh*. and McDonald (Ex. W-171) auu**ttd a tendency fee chryaotiie ta bo removed (ram the tung* bteavia of their obiervetion that the quantity of tremolite in the lung* ef Quebec miner* and miliar* waa aimtiar te that of 1S% of tha control* hod boon axpoaxd 10 Chry iotile. smosit*. crocidoUte. cbrytetjl*. datptto tha minart' much favel* of ehryaottlo txeeadiai t f/ce. amkophylitte. and tremoiito were greatar axpoaurt to ehryaottlo. In Whan Jerry aad Ncwhouao limited tl|pir detected in the lung ipeemen* of the companion to thoia eiaaa and matched ueea end contrail. For ameettt and control* who hod beta txpotad to over croeidolita. about 1 timta 01 many gantroL OSHA baiievea that tha remits of autopsy (todies uf fiber content af lungs cannot serve ta direct manure* of I f/ec of ehrytotil*. a itaUitually mesothelioma cam aa contrail had risk difftraauait by fiber typo. . ignifieaflf'grtattr nuwber of caati bad more than t million fibers par gram of AfotoiAoJiomo Finding!: Am mentfoaod an accupotional hiatary of axpoaurt to croeidolita aa well. Matching tha controls Car the mtiolheltoma eaaat aa yaar af biro camralled for tha important factor of length of fellow-up. OSHA eonatdara that barn crocieelite and chryotil an implicated in the cautetiaa af mesothelioma by thia study, elvysstil* became ltC% af the eatea received htph dried lung tittuo. For aathophyllito. twie* at many csm* as controls hod more than 1 million f/grate. For chrytotila and tremoiitt. little difference in fiber eontu:a wet abiarvtd between uic* end control*. McDonald. McDonald, and Pooley stated: "The equal quanlititt of chrytotila fibers f-uad in lung tittue from uiee and comrala foil ta iupport In the introduction to thia taction, the primary baste for tha hypothttia that croeidolita ta more carcinogenic than other forma of itbeitai i* the abrerved variation In mtaerboiloma mortality among cohorts txpoeed to different fiber typas. A lummtry < tha s! dealha from mesotheliome among eohorrt txpotad to difTarent fiber typat follows. chryiotile etpoiurtt compared ta !S^ af tny aaioeiation botwatn this mineral Meuraan at al. (Ex. H-2SB). who ihe central*. tad creodeltta baeauaa type of aabetts* ..td matothalial tumors. ob**n-td aveasa lung eancar r,jruii!> IK of the cam compared te 7J* of the However, the lunguryiott.'e fibre among anthophyliitc miner*, did not find control* had bean txpotad to content et death mutt be Interpreted any deaths from maaethtlioma in thatr croeidolita. eaetiouily. ta the** fibre* probably cohort Is Stldmon at al.'a cohort of Tha Chronic Hatord Advisory Piatt on Atbestot (CHAP) compared lung disappear in tha coum of bow* (Ex. H- ametil* insulation production worker*. ltt.p.420).' total of 14 tnoMthalioma* wra cancer ntk par unit of cumulative Thera are aovarsl pomta to eenatdar identified by death certificate er axpotare Ixlaa know* at K*, the lung eoneeming McDonald at al.'e itudy. pathological reports (Ex. H'Olf;. Then uncar pataecy faetar) aBeat tha cohort* axpoted to difTartat fiber type*. CHAP reported that ttudioe of ehryaoiile First# If the fibers responsible far inducing meioihelkuna wart alio responsible for inducing cancer* at till* 14 daatha from metathtiiomi SonxtiluUd i.*N of total datthx in thi* cohort. workert yielded both low eod high elhar than the lung end meaotbelium. Cohorts of chryiotile workers had voluee of Kv at well at Audios of then a true effect ef a fiber on rvlativaly low percantagea of drain* creodeltta workortoad amoatto mesothelioma geneai* could fail to bo from maoatbaiiosu: DUP 0907187 JJ W- -' T/ /;. w7 DU 028288 rtdtrai Rttnnf / V0|, ,, ^ , -r<jay S'ovc.-ocr 4 uti / R.,ir end Ktul<,ost mis Tal I *SO?HUOHA OUThS MOW C*TJ Of ChfiTSOTiLt UUC*S Study I Of aeit.M 'row netotwe1'oea HeOonaU ttlal. (ts. |4-44Sf el nan 0.1 hichoUon at a). (Ex. U-0?2] - atacr* o-f Denent tt H. (Ex. *4-022) untie acre art O.S fuel no tt il. It*. 14-044) etnart 0 Hammond at it. however. observed i higher peretntijt of deaths from mesothelioma (Ex. *4-047). Hammond it ai. nudiid iniuianon workare exposed predominantly to chrytottJ* and to ton* amoaite. but not to ereetdolne. Frem deeds certificates ml other dinieal material ITS diatha (7.7*) wire attributed to aiiothilioaa out of a total of 2271 dttthe. Pits (Ex. M-lMI itudiod a factory which used meetly ehrysenia and tomi eracidolite. ind found a high miiothilioma risk. Kobouon it aL (Ex. 14-042) obacrvtd 4% of diitii from anothiUocia to a cohort where tho factory used Uti following percenttgax of aabeetoe fiber type* chrysouia N1. meaite--4J% and ooctdotite OMT%. Among eroadoliti workare. McDonald lod McDonald (Ex. *4-1*41 obierved 11% of Ctithi from Mothelioma. jone* it *L obierved 10* of duths Croat mtiotholioma (Ex. *4134). McDonald ind Fry (Ex. 04-0U) obierved l of dudu (rent metodteHma. ind Hobbi it aL (Ex. *4132] observed t% of deathi Cruel mesothelioma. The Chrome Kaurd Advisory Panelon Aibeitoi (CHAP) Mated that pentontil niMihilioai 'appear* to be moat common in workare Mooted to amoii'e. leu often to crecidolite. end rarely never to chrysolite* (Ex. 44224. p. 127). I lewever. CHAP Mted the large venation in peritoneal mesothelioma eMtiahty imong croctdufitc workon. the tack of rtik data expretied to tenet tf ud tipoturt. aad the freoecM mdiiiHtii tf pentoaseal ssesothetiema. Cuaeemteady. OtAP suggested that faettrt tther tboe fibee typt. Midi aa Obtr dimension. may be important fur induct*oa tt peritoneal, mriotheliuoiu. Fur pkerut mesothelioma. the differences in mono lily among cakone were Mi ee marked at for peritoneal mesothelioma, according to CHAP (Ex. *4-234. p. 120). Summary tfSpidtmiola$te Date; In lummary. there it avtdcnca that ail eommereial aibettM fiber type*. except for tnthophyllfte. couto ctbettotia. mesothelioma. end lung cancer to humeni. Anthophyliite baa been shown to eauio lung car ;ar and aibattotit. but no mitothtbomai have bean reported among werkert expend to nthophyUai For lung eaocir. OSHA viewi tbo endanea for dIffareauali in nik by flbir type n (neonehtaivi tad UteniaUttnt. Some Kudin have found that ehryiotfle workon have roughly the umo or higher nik of lung cancer compared to workon txpoied to tnphibolo fibers, whtlo other ituditt bivo found that chryeoule woriurs had amiwhxt lower relative mfci of lung cancer. Aa diicuned by CHAP with regard to tbeir ecTpanaoo of lung cancer nafc per unit tf cumulative exposure. cennctent patterns of hightr lung cancer nk .Acng wtrken expoied to eroodeliie and amonto did oat emerge. With tome exceptions, comparisons tf lung cancer tick among occupational cohcrta expoied to different fibe.t |oirnlly have failed to control for tho following variable* Fiber eoneintrition* ige distnbutton. and Wttgtb of oboervauon. Then variables are luflictinily important determinants of asbestos-induced lung caneor nik inch Utct OSHA bclievat these particular cross-cohort campartaena provided inceaeiunve evtdinee eoacemtne ditfereneei in carcinogenic potency of the vnnout fiber*. Other important wariobici that may confound croticohort camtunsmi ore fiber im distributions. hygienic measures Instituted by the cumponies. and respire lorusa. Tbo ivuiunuo tor a differential m mesothelioma rsk. oartietiUrW penioneii mesothelioma. uy r;|*r ivpe il more cuniiiitnt than far lung cancer. Nonetheless. thii ividenei loettn not (a bi eoncluiive became of failure ay moil in veiiigitori is important vinablit when eimpinnr different occupationol cchorti. Mesothelioma ruk u ifTeciad by tho umi variables that datarmma the eaaecr fiat Furhcmiore. rnttoihtlient hit ionjtr latency period than asbestos-induced lung eaaecr and ritaa exponentially with Inotiaing lime tinea tmtiai axpeaure. tueh that length of abaarvaticn u a variable that muat be controlled for in acticohort companion*. Quyaonlo la a lung eareiaegen for hutnana. Evan If ehryaotile eould be definitively thown to Induce fewer etcaothcliomea than the other fame of * asbestos. OSHA believta that epidemiologic ituditt mdicata that ehryaotila poaea a ai|nificani health nik Ic humane by inducing lung eiocar and aabettoati. OSHA hae coaeisdad that fiber type is act an important datarmmant of lung cancar martaltty ariatng from aabaatea axpeaure. Became lung cancer ia the maior came of axcaaa monality among aabaatea workare. OSHA doei net deem It apprepnatc tc permit higher level* et axpeaure la ehryaotile than to ether eabeatca fiber typea on the beaia tt the possibility that ehryaotile may indue* rawer maMthtliemaa than tho amphibolei (a.monu. ooeideiite). X Kxptnmuiiai Data. OSHA bvliavea that numerous studias oflaborstory anunaii expoied to aabaatea have found that the dimanaioca ef fibers rather than typea ef fibers are mapir datrrminama of nsk for lung disaua and cancer (Hanngton. Ex. 44-111: Pott. Ex. M-173: Stanton. Ex. 04-03. 04-1P0: Wagntr ct aL. Ex. 44-194: Wright and Kuachnar. Ex. 14-210). Aspect reuoe (La. ltngth to width retiea) of fiban have alio bean uggaitad at faeton mfiuancing carcmogfBlcity (Bertrand and Ptxarat. Ex. O^IHL lecauM fiber sixe distribution spptars to affect disexae. pausing potency, the source ef the asbestos used for laboratory eiportmenu and the methods uud to produce the oibesioc "clouds* should be considered whan inttrpratiAg tht results of (aberetory axpanmoms. Ouyaoulc. omeaiw. and crecidolite hav* au induced cancer in animals upon dmiruatrsuan by mhalutien. inieenon and implanianon (NIOSIL Ex. ts-134. NIOSH/OSI IA. Ex. *4-Jt Weiner t I. Ex. 44-203: Uevie et ei. Ex. 44-1201. Davit et uL found that UICC chrytoule DUP 0907188 DU 028289 SmS Federal Retuler / Vai. <n No. 213 / Fnd.iv. Novi-mnir S lfW3 ( Rules .me R,''ji.iliont produced mart fibrosis ft rets vtn inhalation than did UICC amaiue. Fiaciory samples of ehrysotile. however, produced a similar dcgrv* of fibrous via inhalation eampsrtd to factory tempi** of amoaita. l Wagner at al. eandctad inhalation itudm of i UICC asbestos turn run (2 chrysottl*. 3 amphiboha) in C/0 Wietar rata, and found similar degress sf pulmonary fibroin and lun| tumor inedaneaa for aO aapoatd group* (Ex. MC|. fTha Union intamauonalt Caauo Cancer (UICC) n the aourea for tha aaboatoa fibar aumplta uaad in die study.) Annnala axpoaad to tha Z ehrysetll* aamplaa rotainad much laaa dual m thair lungs at tha and of the axpcaura period* than the 3 other txposed group*. Concantiai Uua study, tha MOSH/OSitA Aabaato* Work Croup eommantadc "In larva of depr a of reiponaa rolatad to tho gsantity of dual dapoaitcd and rttautad in tha lungs of rata, chryaotila appaar* to bo much cert fibreganie and carcinogenic than tha amphibolea" (Ex. 44-420. p. 13). Of tottrtat war* tha mooothaiiomaa oesumni aftar only one day of axpoaurt to amoaita and erocidolita. fstrapltural administration of vartgua forma of aabaatoa producad the following mcidenct of meaothebomea: crocidelitap-41*. tmonta--MV anthophyllite--44*. Canadian ehryaotife--SO*, and llhodnsian chryaotllt--18* (Wagnar at aL Ex. 44- lyj.` In contrast. Stanton and Wrtnch (Ex. 14-4311 did not obetrv* difftrtnen in aaiothaiioma meidanet by fibar typo with intrapleural implantation. Gbrytatil* may act as a ca-carcinogen In addition to aetinf aa a primary earemo|n. Ku.xg-Voaamaa and Vinkmann (Ex. 44-143) obasrvad a itrong tittaraetion between chrytotilt admmiaiarcd intratraehtally and N- ailreaodiathylaauna administered orally with regard to production of Imp tumors in hamster*. N-aitraaodiathylamina baa bean damonatrated to ba carcinogenle to many different apaaaa by many different routaa of adntimatrauaa. bt IP?. Stanton. LayardLTescha. VtiUar. May. and Kent published tha results af wata al 17/ilirats plaaaaa sf varytnp types and dimanaiana (Ex. 44- 083). Thtaa Qbrows plaaaoa won implanted to Ih* pfeurao af faeuia Oibama-Maadal rats, and sanrfvmg animata wan sacrificed altar 2 yean. Stutiatital aaalyaat indicated that tha fibers laaa than ar aauat ta U mierotnaiara (**m| to diaaictar and longer than urn producad the hitthaat incidence of pleura! sarcoma*. Fibers leal than I pm to Ismxth appearud to be inaetivaisd by phapoeytoaia. (Phupucytoais is the engulfing aTTnrstpn panicles by phagocytes, which ere calls aa ihuse less th.m $ micrometers 'em) t* lh( usually digest there p.irtielea in length (F.x. 44-SO) Both rets snd order m protect tha body from them.) monkey* wer* exposed to a enrviotile Si.man at aL listed. 'Since nropieiue asbestos aerosol for tt months. Tha response to t variety of typer of dur.ttiie sunning rat* war* observed for 4 fibers. partieularly atbealoa fibers. u months following the cassation of r nmilur. our experiment* ratnforee tha expoaur*. Neither pulmonary fibrosit idea that the carcinogenicity of fibers nor tumor* weft mereaitd in the depends on dimension and durability exposed ret* compared to the control rather than physicochemical properties rata. Menktye art being maintained for and emphasise that all respirable fibers an indefinite period following exposure should bo viewod with caution' (Ex. 44- to dattrmint tha chronic tfTacu sf 083. p. STL expocan. OSHA believes that Stanton at iL'a study has important implications for tha question of fibar typo differentials u nsk. Tha study suggests that any itIr m ad differanees in nak by fiber r may b due to difTarances ta the fiber sue distribution srithin tho workplaces being compared rsthsr than inherent chemical propantea af tha particular fiber*. Stanton at aL's study suggests that fibrous materials besides as baatot eaa produce n carcinogenic response In both the pleura and pentoneum. provided that these retinal* pots*** carctnogtnic dimensions. Among the fibrous mattnal* demonstrated by Stanton at *L to product malignant tumors following Implantation are: All forms of aaboatoa. Including amoaita. tnthophyilite. ehryaoul*. crecidelito. and tramolltr boroatucate: glass: aluminum aUteata glasa: aiintral wool: aluminum oxide poutatum titanatr silicon carbide: aodtum aluminum carbonate: wollattoniu: and attapulgit*. It should bo noted that Stanton el al.'a study did ot ntla out eareinogantesty of fiban ouuida of tha dimension* shown to bo earctnogonie. Stan n at al. (1P81I continued their Implantation txportmanta. greatly expanding tha number of durable minerals, including aaboatoa. taatad via implantation into the pleurae of female Oabome-Mendel rats (Ex. 44-115). Stantao ot al. tbttrvtd that the moot The MOSH invaetigaiort encountered tome difficulties in trying to generate short fibers. Tha bail milling method was uaad te gtntritt fibtrx. result.na m tabettot ball* that could not mert the dttired XI aspect rabo. Soma problems alto occurred with regard to tha method* *f counting asbestos fibrt and detarmimng aerodynamic diamrtert I Ex. 4^230). Consequently. OSHA eansldtri that Platak at aL's study provides suggesuv* but not conclusive evidence that short asbestos fibers do not indue* pulmonary fibrous or tumors. Some ehemitts have petittd that asbestos fibers have biochemically active iitc* en thair surfaces that ean be modified so ta ta reduct tha hatardout potential of asbastoa fiban (Ex. 44-133|. The alectneal charge ot chamleiil groups on tha turfaet of tabesto* fibers bat been bypsthatixtd to influence toxicity of fibers. For example, oat chemical proeeta rtmavta tha magnesium hydroxide group* on tha surface of ehrysaulc and rcpltcta thtm with sifanof group*, produorti a form of ttbetio* known at tiixiuzsd asbestos. In vitro ttsta (t*tta conduettd on coils in last-tuba stmulttions of bvmg systems) htv* beta conduettd for normal asbestos fiber* and ehemieally-'reated asbestos fibar*. Oeereaitd toxicity m chemically treated asbestoi fibers compared to normal aabestet fibers hat been reported (Ex. 44-113). OSHA carcinogenic fibers wore those 0-23 pm or lea* ut diameter end greater than I ism in length: however, high correlatiaa* with caranogcnscsty were also observed for fibtro 1J pm or iota in diameter and longer than 4 pm. Wrtght and Kuschntr (Ex. 44-210) cantidart that tha hypothtaia that biochemically active site* an the surface of asbestos fibers determine tht degree of carcinogenicity ef the fibers is not well supported et this time. Thu it ^because many in mo studies, especially those conducted by Stanton ct al. have studied tha production of fibrous by imratraebtal injection of etbeains fiber* in guinea pig* They observed fibrosis found that fiber dimension* rather then chemical properties appaarad ta be the primary determinant af fiber only from asbestos liber* longer than to caraaagtniaty. Stanton at al. found that pm. Cibha and Hwang (Ex. 44-124) a variety af non-asbestos fibers count pointed out that industrial ptoeeaaat induce cancer, if they were milled to ualng ttbetio* may roduea dm specific dimension*. The in vitro studies ptrcantnge of shorter fiber* in the air. of chemically treated asbestos arc nut NIOS1I iPlaiek. Croth. Finncib Stoll, dctcnninilivt ol health nsk as the >n and Ulrich) conducted study sf tha vivo studies of fiber dimension and chronic effteta of inhalation of short hence da not rvfuie tha findings of csbeatu* fibers, with short fibute defined Stanton ct al. end other investigators DUP 0907189 028290 Ftdertl Roller / Vol. t. \'o ::J 1 md.iy Vitvomlu-r 4. I'l / Ruli'i und Reg.il,,tiuns JU17 concern:.-!* the overriding important,* of fiber diffluns.an. Therefor*. OSf LA will continue io indud<; chuntic.iUv.ifvjied isbetiut longer (fun $ Bicrometar* with 3.1 or greater aspect retiu m the scop* of th* tsbcs'ot stundyd. on th bam that eheT.ieUy-irtiJl asbestos pcc* health risk similar la fat of untreated asbestos. * la summsry. OSHA regard* expenmeatel itudie* of aruaJa it iugge*ting thet <11 esbetto* fiber type* poutts lutiler carcinogenic poiancy. Animal ttudie* llto suerwl that fiber dimensionx rather thin chemical properties or fiber type may be the trengtsi deterannant of carcinogenicity. in OSKA'a view. Extrapolation of the reauita of experimental itudtea at am mule to the human experience ntcetiuaw* in esaumption that the fiber dimensloni uaed for experimental studies resemble Sber dimenaions in workplace*. Thia aeaumptioo mtfht not ba valid ta all inataneet. e. Ocher Faetan The various typss of asbestos Rben may differ in tho pertantaje of fibers aveileWe for inhalation and the tsn|th af tint that dual cloud* remain airheme (Kowt. Ex. 04-OOSV Croetdolite mijht stuy airbame for a longer period of time and havo a greater number of respirable fibers compered'to emoetta. which in turn may exceed anthephyltiie in regoni to these two characteristics (Muir. Ex. 14-3901. Tho preparetion method for ehryeotile will detamine these twe ehnrictenitiea for Isboretory sample uf (they eettie or foe t particular workplace witn ehryeotile exposure (Rowe. Ex. *4-0*5). Because thicker fibers sutht drop to the ground faster and erueiiiolm i generally finer than the ether fibers, erocidolite ass might Irud tu dustier wnrk envt/onnienis and Iwnca a greator health risk, even if smridoiit* it not mere dangtroas an a fihcr.fur-fihcr basia (Mufr. E\. M-ISO). I luwcvor. most respirable ftlwra. whuh are the fibers likely to eausv dur.iar, mil (end to remain airborne fr Urn* pnrmda of ttmo. Another puml tu eunJt it whether, for difTarmt filwr lips, thr ratio between fiU-rs imblv untie* a microscope ami alnVliiw submtenMcufmi ftlwva vurws. 11110 would CaAfuuati tuotpuneuna hriwtvw cohort* sptxumtHr |nl to the some levels of difTrmn letUic ld-r tuulr th* light ouenswupr. if auirnt liU-rs nut oounted by ike <* upm ul siierosujw awduol |u<w a kaaurd to health tMun.fs M i'.iI OStlA licle-vra that !! v-r I:)"*'- an* bund I" minimi sml u'ltlma utul ttiul labsryuriit iiun>ii. tuiiiia |mrws lend to lur.ih 111" " "Iwit *111! iilm n thntr duftiatei Sated on experimental esperinient.il Hudie*. which hcie findings impticauni long tarn fibers 01 ulisarved esnes* eancar no from b<",ra in* mull utrcinogunic fiber*. thesv etputur* to *11 aibetlus fiuer a* tubscwueiti praratie* stay have a being the most important with n-e.ird to grcir earcinngnnio busard compared th* queinon of diffsrentiel health nsk to ihv mitiol mining ind milling by fiber type*. r operations (Nicholson. 19*1. Ex. M-OTi]. OSHA examined th* ooettion of differentials in earcinogtnic nix among manufacturing practises which fail under OSIl/V i lunsdietiOA Aa U tho cat* for mbits sf fiber type, sou- cohort companion* of processes thould control for th* following vsnables: fiber I. Tftmo/i: and Atuhaphyiht''. Sam* but not pU commercial tale dipesits eemaia serpentu* ssikeste* and fibrous mphibot# esbestn*. including chrytotUe. trtmelit*. tnd tnihpphvllit* (Dement end Zumwald*. Cx. Kleinfeld et at (1M7. Ex wtst) itudiad ihe proportionate itonaiiiy afmuk eoncentraiiorij. duration sf follow-up. duration of exposure, end eg* distribution. To account for th* variable of fibtr concentration. OSflA compared bit potency factor* for lung cancer (KJ 0! different manufacturing etudiee because potency factor* are based on risk per unit doe*. As diseussed ta Section V. Quanutauvt Kill Aaafytia. th* potency factors for lung eoneer wore not consistently higher far any particular manufacturing process. Because potency factor* for miners and pullers in New York State who had bean *xpo*ed to aibastos contained in talc. Ail men were employed during ittf tnd had IS or mure years of exposure during ]940> 1M1 Of fl deithe in th* itudy whorl. 10 (11%) were from respiratory system cancer end II (hiss) ware from pneumoconiosis or csmpliceueits of pneumoconiosis. Kieinfeld et *1 calculated that only II (i^S| deaths from respiratory eystem canesr would mesothelioma (KJ could ho calculated have boon expected, resulting tn * for only e itudiet. OSHA could not greeter than J-fold nsk of respiratory compart hV fot different manufacturing procetsea to summary, eaneer. A follow-up study by Kamftld et tl. (1(74. Ex. M>141) included 300 thart doee not eppatr to bo a eonsietant pa tiara of differential lung cancer nth workers exposed to ssbeits* in telr. Of th* to* deaths observed. 1} (I27t) were oy menufectunng ptoceee. Therefore. from respiratory eoneer tampered to e OSHA deems it appropnete ta canttnu* to apply 1 single PEL to *U segments *f (S^B) expected. Tb* high proportion ef deaths from pncumoconioei* may have tnduetry covered by th* Agency. Relatively thick respirable fiber* tend reduced th* number sf death* from lung esnear. to lodge in th* lung while thinner fibers Klvduotn et *L (Ex. Mtn) end can travel to the periphery sf tho lung, Nurminan et *L (Ex. 04>lfl) obstrvtd and panatrata and than lodge in tha plaurs. Thast fin* fiber* lodged in tho pnoumoeoniesi* tnd txeats lung cxnear mortality among Finnish worker pleura might b* the mduccre of exposed to talcs containing fibrous maeeiheiir sa (Nicholson, tpgl. Ex. *4- snthophyUit* and fibrous tnmolitt. No 071). Bignon et *L (Ex. Pk-lOS) studied deaths from matathaliam* war* th* lung* and pleura* ef thipyerd reported by these inveetigetsre. workers. ..xl found larger fibers, Yatleioglu. (leayio. Eslei. Saytt. tnd especially empbiUtee. in th* lunge, (n Yorulmet (Rx. kWUl rrpontd a high th* pleura*, fine tad email fibers, prevalent* of pltarol calafrcatlon and usually chrysolite, were found. thickening tnd a high monthly rst* In summery. OSHA recognize* diet frr r mttaihtlioms among rcsidemt of the fiber type* may differ with regard to Camik. t town in Turkey m which there ihotr tondonnee to break mi* fin* fiber*. era many dapoeut af tsbatitfemi Crvcidalit* appear* to divide mis finer minartl* which era used as construction fibers more readily than other etbeeto* materials. Th* canstrychoc runtnaii fiber types, which may render it more hazardous. Manufacturing process** Hh*v* b*n shown to contain fibrous trtmolit*. tmigont*. lixardiie. chlorite, could tnertes* the curcutogeniGsiy of and talc Yaeicioglu tt al siso rtponed sbastot by tenanting fiber* that ere an *te*u of lung cancar in ihu thinner in diameter relative to mating population. end milling processes. While these Brown. Dement, and Wagoner of factor* ar* astercsting and contribute to NlOSlt (Ex. 04-<B51 conducted * the formation of hypuihetas regarding hismncal protpectiv* studv of tale th* ewchamtmt af asbesto* minor* and millets #f one esmpuny in Curanoui-nuxit. OSllA bvlievtt that N*w Ynrk State reported by the thine factors do not provida * definitive company to be mining laics not an*n*r tu the question of possible crwtaimnc asbestos minurun. N'lOSH itiditrittial* in nik by fiber type. OfiltA (Dumeni and Zumwahlcl. howeirr. h;id m-wi the daw from cpuiumintoyic and rrported asbestos exoosur* m the tale DUP 0907190 DU 028291 str.a federal Repnter / Vul. ag, \n. ;;j / Frid.iy. November 4 tqay / RuIm ,,,(J RP5V!|.lhorf sun* and mill. NIOSH conducted aa btdustnl hygiene lurvty of the study tale mm* ea* a neighboring t.ile aunt inown la cantata ssbtttoi fiber*. Silica exposure* were found to be vary low. wall below MOSH's roporamended PQ. fur silica. Radon daugt^gr veasuremema made bfiJia Mint Enforcement Safaty Administration (MESA) showed only ail ta tract level*. Oemant and Zumwslde found that expoeu/e chartelanstica batwaan tht study aunt and aatgnbonng mint ware aubataodally ainuiar Ta fad tht aiiianta dut sample* (rate the amt and aiU studied by N'lOSH and oaiataiatd by tht company ta be ttbaaiaa free wttt found ta aantaa a hiffur proponts* at positively tdastnTiad tibtstiftna emphibele* Itfetiy dw te a higher ttaalitt eaattai All ether fiber ehsreaefisue*. such a(s| audio* lattpiA. diameter. sipac ratio, and properm* Ina tfcaa I Im m Ititfth. war* nat lutisiiully different at tha J leuel" (Ex. **-tl. p. tot. Tba NIOSH atudy eohart (Brow* at aL| sonatatad of all whit* malt* amploytd sometime dunfl| INWIH Vital atatus ef tha 3M eohart member* waa determined as *1 |unt XL l*7t, Comparuien waa mad* ta age. calendar period, and eauaa-tptcific mortality retaa of U.S. whit* mala*. Sipnfleant tr.ertatt* In Hmg eanctr mortality (I obsarvad death* vena* U expected) and tta-asalignsat raapintary diataa* martality (I obtarvtd vane* lb expected) war* observed. On* drath fret* maiothalloaa occurred. Since tha iadividual who ditd from maaathaliema bad previeutly worked in tha oanauvctlea industry. his daath eeuld not be definitely aaenbed ta hta exposure to tremolit* tr anthaphyUlta. Of tha 10 individual* who died from mpiratory aystam cancer.3 had previously worked fat ethtr New York suit tale companies. NIOSH investigator* also addnsaad th* potential confounding affteta of ci ts**ttt smoking la their opinion, a cohort af heavy smoksn would havt no men than a 49% incrcaae in lung cancer risk to relation to all US. whit* mala*. Bacaus* they abecrvsd a greater inert*** in hm| eanepr risk. abnoat J> fald risk, thay |ud|ed that dgsrett* snaking waa unlikely to account far th# obaervmd aecatt lane cancer risk aaaog tfctaa tale Risen and rnllltn aspeaedt* aabeatee. Tha meat lacttanal morbidity aurvty taodvewd by NIOSH in 197* fouad a 4** prevalence of snaking. a pmslcne* ainHor in thet af U4. mala*. Bratvn. Dement. and Wagoner (Uteri' that "sxpoaiut* to aabetufona tremolit* and anthophyllii* ttand out aa th# prias# suspected ctrclopc factor*" ataaoatad with tht abscrvtd txetti risks of lung cancer and reipirutory diaease. They cnnk.'udad that "exposure* to talcx from tht Uouirmevr mining tret are associated with an increased risk of brenehsfcnie cancer and non.mnlignnt dutussi of tht retpir tory system" (Ex. M-lgl). As mtaturtd by apticai mteroseapy. svr|t sir coneamrattona of fiber* peatsr than S um in lentih renped from tJ f/ea to *4 f/ee a* an p-hour umeweighted tvtrape far P different fob btlea in tht mm*. In th* mill, tvtrnpa air concentrations for tueh fiban raoptd from u f/c: ta M f/ee aa an a- hour tm*.wti|hitd avaript far II different jab title* (Ex. M-1P1. pp. MOk In addition to th* txcaaa mortality from lunp cancer and nan-eialipnant reaptratary diseatt ebaarvtd by Klainfald at al. and Brawn at *1. atimareua ttudie* of tale minan and aulltn txpeted ta aabaato* eantamtd In tales bars tstablfthad that that* warktn havt a biph pnvalanc* af pleural thicktamp, pleural calcification, decrements in pulmonary function, and fibraaini lunp diataa* (Draaason. 1(33: Drtttttn and Oalla Valla. 1KU. Siapal at *L lb*i ' -v - * and Durham 19U Mtaaite at tL Its* Klainfald at tL IMS. 1PM. IMP. 19M. IMS. IMS. 1P73: Maurman at tL 1174: KIviluet# at tL 1PM: Ahlman at tL 1I7X Poire at aL lMi Ex. w-lti). Many af thaa* atudiat avert conducted In th* tame ptopraphie aiea aa th* atudiat by Brown at al. and Klainftld at *L A cress-sectional morbidity study of tha asm# company wheat martality experience wet etudied by Brawn ead csflcapuM waa performed by NIOSH investigators (Gambia. TelUiar. and DeMeo.Ex.aa- .). At discussed above. NIOSH eantidared that Out company's workforce waa exposed to ttbttte* contained within tale. NIOSH observed nurkert Si tabeitoe expoture fss the iunpt af thaa* worker* in addition (a mpirotary symptom* and Lap function dacramanta. Of 15P malt minan and mtllm. in participated in th* asrvey. RaapMiory questionnaire*, cheat X-ray*. and tpiramotric testing seem, administered to partleipauni warktn. Comparison af respiratory morbidity was mad* t* 9347 coal miner*. 1097 potaab miner*. ehryeeult atbeatot worktn and aymhette wool taxtila worktrt- OSHA conaidtn that on* af th* major ttrenptha af Camblt at ak't erew-tecitonal morbidity study was th* ehaic* af campariaan population*. Besaeaa taler cc.' end potash miner* are likely to b* similar in many nonaccupailonai f.ietort that may aiTact reapiratery morbidity, the liketihood of observed difference* in rcaptruiary morbidity bainp due to tpaeific worlpiece exposure* of the t.iie wnrker* rather then othrt nik fueian for mne discus* i* prtitlv mcreeacd. Comparisons with the coal and put.nh miners wuru strutifird liy ege. hcpni, smoking status, and duration af 1 employment m mining. Compared la coal miner* and potash miner*. lb* talc worker* with no previous occupational exposure within other talc mine* and mills had statiaticaily significant loexeasts In plaural thlckeninp and a higher prevalence ef pleural calcification. When all talc worker* wart combined without regard to previous occupational exposure to tale. Inertaaad prevalence* ef cough, phlegm production, dyspnea, plaural thickening, plaural ealcifiesuon. sad irregular opacities on tht X-ray* were obiervtd in talc worker* compared t* ta* or bath mining control srmipe. In addition, tale warktn had stgntfleamly dteretstd pulmonary functtM (TXVi and FVC). Deeretied lung function waa associated with Inoeaaad cumulative exposure* and lengths ef txpotus*. Talc warktn had a similar prevalence of respiratory ij-mptonu when compared la chryaatil* eabcetoa workan and a much higher prevtleace af ayiaptanu what compared ta synthetic wool taxttl* worker*, in cantreat, plaural thickening was four ban* aa common ia talc workara comaartd to tha chryaatil* workara. Smoking was net faund ta b* ttaociattd with th* obtcrvtd ndiographie changes ia talc workers. Regarding their studici ef morbidity end martality ef warktn tipottd ta talc containing asbestos. NIOSH concluded: *A thorough review ef th* ivtilebl* literature armoatuttid diet fiadings af thr proetM studies tn m agreement with these ef ethtr studies ef ecauaaiienat groups txpeted ta <k* saa* tr siaiiar auntrau ar einaril muturoa. Tko la eepeeatly trot (*r tecsnatianal txpatant ta sniheehyliite iiknw. Thee* findings B*u it unaerttiv* that urorhtn from tha mna and mill studied, kdretro he reunitety afeatrued uautf meduial surverllanct entuna antablishad in tha Obi IA and MSHA athrnua staadarp. Furthermort. ail prm iaians af that* sundsrds should be (oiiawad darurg tht producuun tnd auhtaquant aaa df th**e uiea* ltx.**-iat. * 8h Stm* tnd Tabanhaw (Ex. P4-1PG) of Tabtnhaw Occupanorval Madicme Attadata* studied *11 mala worker* employed tomeumt during IMP-1977 at th* tale mm* and mill studied by NIOSH A toaat of TOP *rn wan alipible far tba atudy. and vital status ns of Decasabar 111P7I waa aacertaintd for P72 af th* men. Of th* TOP men. S3 DUP 0907191 DU 028292 workers wen txdudtd because of!lcj, of on occtfie vnbio. Having i cotton ol Hi tor inalysi*. Compariiun waa made lu age. calendar pcnoii. and causa-apaeific mortality rat*! ol L'.S. while males. Tot the overall cahari steatite in mortality that warn notktaustiealiy ugnifieant won obiervtd lot lua| cancer and non-mallgnani respiratory dliim. Sulla and Tabanhaw judged that iba ooa.aigmfieant ticaaa ol lung canear <i "eoniistant with a smoking affect* ralhtf than an affset ban occupation*] exposart (Ex. U-1M. p. *!> Stiil* and Tabanhaw alao separately analysad tha mortality ol tht talc workara with a hiatory ol any work txpanenet before amhloymtat at tha tudy nina and mill This prior urark txpananca included all araviau* job*, not only job* at othar tale rninaa and aillla. For this aubeshon ol MO wblta malts. mortality from tha following causa* of death waa significantly aJavatad; all eaneara (SMRw ttt). liver eancar (SMR * 1033). rsipiratary ayataa eaaear (SMX 2211. lymphopoietic eancar (SMXw37aj. and nan-malignant ttaptratary diaaaiaa (ShfEwSCTI $11%, and Tabanhaw stated: 'Since tha easean and lung dijeaaaa typically bava long latencies. tha posubiiitv tutu that capaaum prior ta wark at liaTMX study nina and mill wart ttapaaaibia for at laatt tome a( theta distaatt* (Ex. M1M. p. <42). Whan tha mortality ol tha subcohoat with aa work axpenenea prior ta employment at tha itudy mme and atiU was anatyaad. na eaoaea of death war* la txcuti. in fact, tha SMX for all cauaai waa ti|nificamly daavaaad (SMB >10). Aa would bt expound, thii cohort woo generally igsr than tha cohort which had provioue work txpananca. Stills and Tabanhaw eharactenxed thaaa flndinit a a followt: (1) -Worker* with `taduaivo' TMX (atady mine and mill) employment aaam to be at no considerable nak of having lung eancar davrtop" and 12) 'txpoturet at TMX team to be ncnciranottwe" (Ex. M> 191 *031. Brawn. Beaumont, and Daman! at NIOSH commented as Stfila and Tabarahaw'a tttidy (Ex. **-11*. p. 171; Ex. **-3311. listing tavarmi proWarn in tha analytit by Safite and Tabanhaw that coaid account tot tha different ceoduaien* ot tha two teu ot Investigator*. Ftm. SttBa aad Tabanhaw fatted ta atwiyM mortality by length id feBawap latency tntaml). Brawn at aL thowchi stmh on analysis waa particularly important Avon that ncantly him! worker* were allowod to enter the cohort aa Iota aa ana year before tha iludy cut*off data for vital (tut Second. Brown at al eommanlad lh.it Sulla and Taberahiw'i division of tha atudy {roup into lubcohona with and without work experience prior lo their employment at tha itudy facility raaulttd m "aaltciton biaaai inhtram in thu definition of (ha tubeehorta" (Ex. Sa na. p. typ). Tha lalaction biaiaa which landed ta Icasan tha tututlcal power of tha aubcohoR without pravtooi work axstntnc* included tha ihort lan|th of followoin. abort duritiona of axpoaura. and small i(xa ol the aubeohon Braivn at aL luted: `Any mortality analyata baaed on aueh a amall cohort with lenorally chart latincy it not liktly to be vary irtforma tivo" (Ex. awn*. p. trt). flurd. Irawn cl aL crQdxed SUlla and Tabarahaw'a analyata concerning tha duration af employment af tha lung eancar eaaat. Thaaa tnalytat auminad tha ebaarvtd lung eancar death* without calculating tha txp*clad number ot deaths lot each lataney catatory and duration af employment category. Is addition. Brown t *L pointed eat that Sulla and Tabarahaw'a conclusions had cot adequately tcknowladtad that many study facility worker* bad bees employed by neighboring tale campanil! with exposure* aimilar ta thoaa af tha study facility. Eraw* at al eoachidad that Saida and Tabarahaw'a (apart did net adequately addma the question ol ineqaaqd king cancer risk from working at the atudy facility. In addition to tha poiau discussed above. NIOSH alio commented that death eerufleet** aheuid have bean eadad according to tha rulaa of tha (CDA in affect at uta time af death aad than converted to ither the rth or eth ruwiiun ot tha ICSA for analyst*. rath: 'Han coding tht death* directly ta uia Oth revision. NIOSH also had qvstttona concerning tha S3 worker* tiimmatad from th* cohort and haw woikcrt lost to follow* p war* mated In tha analyei*. Tabanhaw and Thompson raapondad to tha NIOSH ennqut with tha following comment* (Ex. 14-211). Tint they ated rnimral aacmiata and laboratonat who ditagraad witu NI0S1 I t method af Identifying atbeste* in ailicata mineral mtxturat and who did not Find significant asbestos eancantmions ta tha talc practised at tht mine and mill. Second, they ttatad that talc ora at th* atudy facility waa not umilar to that of atkar talc rninai ol upaiaia New York. Third. Tabanhaw and Thompson raittratid that tuny of tht lung cancer deaths occurred in ihorMtrm workrra employed for less than one year. In their eptniuA. this letsanad the liktlihood of the lung cancan being attnbuubit to occupational axpoaura at tha itudy plant. Tub*rH*w <nd Thompson io pointed out that only on* u,c multr developed lung eancar. despite the historically hithsr exposures ot talc miliar*. In conclusion. Tabcrsnaw mar Thompson timed that application ol the ttbestot standard to th* Vanderbilt workforce was unwarranted bated on currant avtdanct. OSHA calculated a statistical pewer of X* to dotect a SOt (oertata In nak of lung e*nur in Soil* tad Tabenhtw ubcohort of workar* with no prtvnua work txpcnanco. (Sea Ex. to>)3< for a ditcrlptien of how OSHA etleulattd ilatiitical powar.J OSHA coiuidon that this vary low statistical power support* NIOSir* crtuciam of tht aanattivity of Still* and Tabarahaw'a study dtiign. Tha statistical power would have basn van lower if it had basn calculated far tht group of worker* with it lean a yon* of lataney. Aa diacutsad tariitr. crats<cohert comparison may bt probitmaue if th* *|* distribution*, duration* of exposure, and lengths of follew*p diiTar ameog th* cohort* being compared. OSHA bdirvsi that this tppaart ta b* tht cast with TOSIA's companion af th* tubcahorts with and without pravtou* wark axptriaaca. Savaral points an fwtabl* with ragard t* th* quaatian of th* thart-tarm workars wha davaiepad lung eanear. First short durauon* of txpesurs may raauh in high ctsmulativa dotM dspsndlng span th* intensity of th* txpotorr Second, the phenomenon of (hort-tsnn sshastoa txposur* and aubsuquaat diataaa kit bn cbsarvsd In othar apidamiologie tiudtaa. Third, if tha majority of panon-yrars.ti-nxk wara eonmbutsd by ahort-tarm workers, the. finding moat of U>t lung eancar deaths among that* workers would not b* unusual. Alto. Tabanhaw and Thompson did not ditcuat th* txpacttd number af lung eancar deaths whtn they mtntionad th* imgla lung eanetr death among tha study facility talc milltn. In 1M3. Concultantt m Epidamtslogy and Occupational Haslth (CEOH) praparad another analyst* ol th* mortality af Still* and Tebarahaw's study ecihort IEx- aa*2S7|. NIOSH raviawtd CEOH'! snalyiia and at* tad; -Ahhsugh th* findings af that* analysts appear t* aupport thtir (CEOH'11 hypothettt that tht talc is nats-carcuiegenib tht raiulttni ttatittical iruiysas art based on ouumtlitns. tniatl numben. and short lottney. Therafor*. tht CEOH conclusions art based on anilysei that sra tnhotantly deficient in being able :a DUP 0907192 DU 028293 51120 federal Regi*tr / V0|. eg. Nq yjj j p^^jy, November 4. 1083 / Rule* nd RcguUiior.* detuct true n*k m in e.iposnd population' (Ea. bW?!, p. 3). eoniisttfii with that* of numerous oihar crocwiolii* and a-no*ua appear i \,yt >udi*t. OSHA believe* ihut tha Had a kighiv proponiun dcathi (njm Smith. Hubert Sobcl. and Msrgust ptdamiologie atudy of tha ule company mcaothoiioma. partiruuny pctnoneji iTx. 14-1 Ml ttudiad health iffecti of talc conducted by Stillc and Tebershaw of matetholioma. comparad to containing iibeitei a kborstory Tabormaw Ocevpelianei Mrdicur* occupationai cohort* axpoiad to tnimali- Smith at aL imtimtiiertd Aitodtia* h* tanout Imutntieni tuch chrysolite. Nonetheless. OSHA is unuCta mtripleunl infection* If a different that it Ooa* not refute the hypothesi* to charaettns* this evident* a* frtmobtie ub*t*nc*i ufto hamsters, that ule eanumtna aibattoa po** a eondusivo bacauaa moat invtstigjior* including Obrtui trtmoiitic uk Cram lung canear haxard to avpoaad worctr*. failed to control for Cbar ceneantrution. Saw Yori itata. ertmolile preportd from Smtth at al l xpcnm*ntal itudy length of observation, aad aga trtmofitie tale are of th* facility etudied abiarvad potitiv* finding* af distribution whan making croapcohort by MOSHVtaoliie prepartd from tumongtnidty Cor nbaiuform tale and compartaon* of mortality from western U. trsmolme ule ora. lid nea-poatUw finding* for tha tale from matothafioma. Cemrolling for langth of aibnufora trtmolit*. Period* it the facility itudiad by MOSH however. abiarvatiao la particularly important obatnatian ringed Cram 330 day* to 100 OSHA think* that limitation* of Smith *t bacauaa mesothelioma siuully ha* a day* attar injection. Tamer* tad plaurel it.'* *tady tender It* findtags latancy ptnod of 10 ytort or mor* uni Rbroaia wart observed only ia animal* tncomdusii a for talc from ta* faetiity th* risk riia* upcnmtuUy with aitctad with asbast.form trtmolit* and itudiad by MOSll la any event. the . iacraaaiag time unca initial axpoisra. trtmolit* prtpartd from waattri US- peaitiv* human finding* outweigh tha Lung eancar ia th* maier e*u*t af trtmoliUe talc on. Smith at aL CauJtd eon-pottlivt animal findings. Talc* kibactomiaducad occupational that tha taoplat of aibettlfam aanuinmg simri'os mineral*, therefore, Bortaiity. Maiothalioma and aib**rei< trtmolitu had greater proportions of long tppaar to po* a tignifieant health risk also are lignifieant eaum of axeasi thin Gbor* than tha iimpla of trttnolite la axpoeed woiker*. and talc warfcan mortality among aibeitoa werken. from tha facility ttudiad by MOSH. . exposed ta aebesto* should ttomv* tha OSHA ha* concluded that thart ia a Tha iample of fibrous trtmoiitic talc protection affurdtd by th* asbattat grave nak for lung eancar and aibastoil* from New Yori itato alao w.tatnad lent thir. fiber* and Smith at *L lunosttd that tb* *r*atl\-t mult* from thit particular tampia wart dua to ft* much lewtr ettmobt* content relative to tha eaicinopanic samples. Smith at aL nutated that tha tampia *( trtmoiit* from tha taerlity ttudiad by MOSH may bavt failed ta indues tumor* baett** of the ihorttr lonyth of fu fiber*, dapitt it* high trtmolii* content. Coamanhng as thetr tomtit* and on the fret that the earcinoinnle tampiat cantaintd material other than tremalit*. Smith at al. stated: " ' ' wt canntt he suit ft*< tha* activity ia due wnolty. or (vat in *ati t* tmtokta * * * ean*>*trueaainlb*|*it aal merely ta tka ameun: at tamaluc. but ala* t* attar facte**. lark aa ttc ttr*note*tt caattcjar.itiua ai tta mineral' I*. a^lta. *. sat. OSHA eenaidart that tntarpaatation nf Smith at *i.'s Onding* I* limited by tha mail number of animal* itudiad. abort aurvtval lima*, and then panada af ohacrvatierv In aummary. OSHA esncludct that NIOSH aiudiat have ahown that tspoautt to atbattha whes it <* present tn talc appear* to hat* rnuitad in tscoa* mortality from.kcg sicca* and non-malignant ntpiratocy dtaatas and ncoaa risk of alamni thickening and lung function dacnmtfin. OSHA ia cagniaaot of the Cam that ulc mining standard. OSHA not** that th* broader among workar* aspeaad ta all tibaitot latv* a* ta which mtnaral fiber* or* to fiber typo* *nd that workar* need to bo be taeiudad in th* defialtian < ssbesto* protectrd from thai* riika by this ETS. will b* part of tha rulemaking for tha which tat* th* Iowan PC, that it parmanaat staedr'd. Thu ETS acuon feasibl* at thit lima. Ai * practical do** not change th* dtfitibos af atbaato* a* found ia IllO.lOOt. I. Summary- Tha tvidonct prttamiy rrjvlatery andpaint. thtrafprt. it It btcaaioauantial whathat tha moMthtuam* risk ta graattr for ctrtaia before th* A|tny indicate* that all Shot typo* that for athtr types. asbestos fiber type*, nap Car Eaparimttttal atudit* of animals Hart amhaphyliUo. esuti lung uoesr. matothaiioma. and ssbesto*i*. Aflihephylliut cauaa* luog caaeer and tibtatoiu. Matathalitma bat not batn reported ia anthaphyilita worlar*. For tun* cancer. OSHA nett* that inconalatent and inconclusive finding* with regard to differential nak by fiber type have been abiarvad by different t&vestigatore. Sumo ttudiai bavt observed the sum* aa higher lung eancar nak in chryiott't jvarken esmparad to workers tapoaao toamphioait fiher* athtr studies obaarv* lower nak of lung canear tn chrysolite watiar*. For aaample. high rtiptratory canear rink wat rbuM d by Damant and collaaguts amang chrvsa'.il* ttiul* worker*. Aa tb*cui*d by CHAP. eoni*tmt patttmt of higher lung cunctf ruk by fiber type did aot emerge. With atm* exceptions. investigator* generally failed to control - found that ciuyietfit la aa lasat potent a carcinogen aa ethtr sbstaa fiber type*. Om study found that chrysotilt waa mar* carcinogenic than other tibostot fiber* whan administered by Inhclatiotu Many tvparlmtn'il itudies hav* rtporttd that fiber dimaniioa t a vary important dttcnnir.ant *' *a.*csnogcnieity in lalioratory anmi.it*. l'ibari lrn;*r than 4 micromatsn (urn) and with dtaetticr* of IS am or lea* hav* batn implicated a* tha most carcinogenic fibtrt. A variety of different natural aad synthetic substance* having fiber* tenser than 4 um with width* of 1J um or less hav* induced ranter* via impl miation in laboratory animola. luegesting that the chtmicoi proportia* of asbaitut (luch as fiber typo) and *an>*ibaste* fibers may not affect carcinogenicity but thut fiber for verteiiita affecting lung eartoi r nak when comparing the mortality of different aceupauanal cohort*. Among tha important drttraunanta of lung cancer nL. which war* net eonaiaitntly dimtnaiona may determut csrutaoscrucity. Thu*, m OSHA* view, animal studies da not support th* hypothesis that there *rc difftrenee* in eardno**mc potency among tht %nous and milling in the alitanc* af atbettot aapnauio tan rtttll In pneumoeonjoex Furthermore. NlOSlft IbJinc* on motiality art consistent with that* af Kle(nfrtd at *L Kiviluat* at ulNuantncn at l_ tad YmxicjuuI* at at MOS! f* auHUidity finding* ate coatruiied for. ara fiber cuneanttnuon. lututtb of obtcrvtiien. and aga diatributiun. , ,_ OSJ tA views tvidenca for differential mesothelioma ttak by f`b* *ypa11 . suc*iivc yet not cunduaivr. . OoCupniMoai cohort* aapotad to filmr type*. Fiber typo* may differ with regard to the fineness of fiber* used in inrtuitn.il procciM*. Finer fiber* may be nuire carcinogenic according 10 ummut tudie*. and eroc.rtelite appeart to be divided mor* readily into fine fiber* DUP 0907193 DU 028294 ftdtral fteaiiur ! Vot. <a, No. 215 / FHdiv. S`ovcrr.bcr i. *,983 ! RuIm md Ret,.*- cri j.i then other etbettc* fiber types. Also, ceuetd ticenanorteltty end disability from lung esneer among wotken manufacturing processes nwy brook In tpidemie proportion* among tome receiving relatively low cumuietur fibers g*n to generate fibers thinner In |ruus* ef expoeed worker*. Atbeeto* txposurca. WttU *t *|. end MeOoncid tt diameter thin than found in the mining causes non-melignent respiratory. *1. d>d net obeerve increased iung ood milling prostates. dlirate. which can rttvlt in compiet* cancer atorteiity among workers NIOSH seentuts l Sown. Doment. diubility khd death. Aibcito* eito rseotving reletlvtly low cumulative * end W nonerl ebeervfd otenlive cauaei iralignem mtjoiheiiama. which exposures. Otspitt some inconsmtncics mortality fro* lung center end non- la uaually rapidly fatal, and lung cancer, in findings regarding nsk from low melignent respiratory disease among which 11 utueJiy fetaL The carpal cumulativ* exposures. OSHA conifers worker* m oao gloat upend to talc reiationihip between eibeetet exposure that tha many well-conducted studies containing eebettoa. A morbidity eurvey and disease has been aatabliihad by e which observed substantially increased of the him pUnt found increased mk of multitude of epidemiologic ttudlea risk of morbidity and mortality among plturel thickening ond tun| function conducted throughout the world, worker* receiving low cumulative decrements. NfOsff concluded chit including the United Jute*. Uaiud exposure* er* evidence ef ngniflcant increased nek of lung earcor ind non* Kingdom. Canada. Australia. Italy, end hsurd at exposures allowed by the snalignent rttgirotery diiooto woo Finland. Furthermore, atbeeto* ha* been existing PEL Section V. Quanuiatnt opparoni In woekon exposed to talc shewn (* cause exerts dieeiit io ainy Ritk Anthill, will discuss prtdtettd containing asbestos. Kleiofeld ond different occupational anvtrenmanu. risk from exposure to OSHA i PEL eoiltagui* also observed txeast lung cor.eor ond rtopirntory diioooo mortality omen* workers expend to ulo esntoinini ooboitoo. ond numerate morbidity surveys have documented respiratory diseiio oxcooioi among ulc tuners end miller* exposed to asbestos. Suite ond Tiborviuw conducted o itudy which they interpreted tf contradicting NlOSH'e findings regarding exeoeeivo mortality omong ulc worker! oxpoted to eebeetee. 5till# end Tobonbow'e etudy hod serious methedologtc ** limitations tueh that NIOSift wndssion* cull appear to bo valid. While not oil Ulc product! eontout otbeitoe. OSHA flndo that whan oibtitoe minoroio ore contained ie tile product!, then eppeoro to be a health nek ta axpoeed workoro. Pneteai administrative aofinderaUoni aim art pertinent to tbo eueetiea ef making regwiatary distinetton* by fiber type. Jevtroi type* ef eebeetai euy be ptetem in the tame workpU.ee. n * <he eeee far tneulition. ereitiflit eoneideroble mresaremeat difficulties. Determining aebeatoa typefel within <ch workplace aught complicate complienee end expoeure monitoring. However. OSHA ie aware that the United Kingdom hoe been able to overcome each complication*. ta euaimary. OSHA eundude* that on tbo ban* of the eptdemMogtc end (xpcriatenul etudio* reviewed above, it U net eppropnate at tfcia urna ta nuke distinctions try fiWr typo for rtgulatory purposes- Aesordiotly. avaatiuuvo analyee* of ruk ehoeld boa* estimates ef tsetse riakspatlrestee fibers aa a whole rather dun on operate fiber type*. Previeune ef OS1 lA'e atandard for oabattoe. mrhadtxa the permissible exposure IM*. abatuM also both* earn* far all eumrerrically aaed eibaataa fibar type*. f. Conci*",a* tuning with mining and milling it A number nf investigator* havo aibeetoe and continuing to ceuee diteai* in various manuctunag prsccsasi euch a aibeetoe lexttio suggnied that different fiber type* of asbestos ksve difftrexeet ut their ability to mduco mesothelioma. Specifically, production and aibeete* cement production. Aibeetoe also hat boon croadehte has been hypothesized to br the moat baxardoua typo of asbestos hewn to ba extremely hazardous whan baeaua* af suggestive ivtdeae* that usad as product by insulation worker* ladicatat that thn aiiothclioma risk nd shipbuilding workers. Nanuroat scientific organisations and agancte* have reviewed the keeltk dots for aebeuos end h*v concluded that atbeetoa exposur* causes hmg cancar masacheiiama. and esbestnets. Ta determine tha potantial a(i kaaardou* agant to causa disease at tow exposure*. OSHA has examined the rasuits of studies it worker* rserving low exposure*, where such studies are available end have sufficient sensitivity to deteet excess risk of distaso. OSHA hat alia aitamptod tq prtdiet risk at low exposures from r.sk observed at high exposure* by using dsst-extrepoletiea models (t* section V). loth of the** methods ef evaluating nek at law exposure* er* valid. Studies er* not available of worhors expoeed solely t| asbestos levala of 2 f/ cc which hove sufficient cohort sits end long rnovgh follew-up ported* to permit obeorvatfon of itiotiin in eanetr end lung disease mortality. Studies art aveilebl* 'f worker* with law euauiativ* axpowra* to eebeetee. however. Workers expoeed 10 yeurs ta the OSHA ftL it t f/cc would have e cumulative expoeure it too f/ce-year*. " may be higher for eoddofitt exposure than for other asbeatet types. All comaiirdeJfy ated fibar typo* have induced lung cancer, mesothtiiom*. end eibestoai* in exposed worker*, except for anthophyiliw. which has induced long cancer and ubestosis. OSHA regards evidence for diffarcaoaii by fiber type In lung cancer risk and osbtttoais risk es being inconclusive and inesrjittem. However, evidence for fiber type differentials in ritk with regard ta induction of mesothelioma, particularly peritoneal mesothelioma, aspaan ta be more consistent, bated on epidcatialegic stadia* of occupational cohorts exposed to different fiber types. Because variables that effect the sensitivity of studio* for detection of nek af mesothelioma have net bean eaatrailad tor by most Invastigeton compering different occupational euherta. OSHA view* the evtdsnco for fiber typo differential* la mesothelioma risk ae ineoeeiusive. Ameng the venakfes that influence the appearance of measriholtama are length ef ebeervetien. duration of exposure, fiber concentretie* and aga dtatrbunon. Hence, studios of worker* with U la poaeibia that mesothelioma ritk cumulative empoeum cioae ta or below may lie higher from exposure to finer 109 f/ee-yeer* provide some evidence of Ohm. and that operation* using nsk fms working lifetime expoeure* to crecidolite may tend ta break fibar* OSHA'* FtL Studies finding adverse span to make them mere earemogeme. pulmonary effects or excessive mortality Studies M labersteiy emmels have not from lung diaaaea from exposure doe* cuoateteady ebeerved diffcrenual nsk to or btltrw too f/ec-y*ir* were by fiber type with regard to induction of conducted by Deny *t l. McDonald *t pulmonary fibrosis and cancers: m feru aL Oemoni at al. Barry and Nawi.ouea. some studies in etumalt huvt found and Finkalataia. Dement et aL chrysolite la be the most carcinogenic Aslx-sun pirw-i pm denser to ihe . Finkxtiictn. end Henderson end among the various atbeeto* fibers health uf pv|"'wnl Murker*, having Enieriine else observed exceu mortullty totted. /i DUP 0907194 DU 028295 5Vi3 Federal Register / Vnl ag. ..s / pnd.iv. ''-nr1*' * UuM <i ih# mjior r.uue of V. QuannUlive Risk Anslyw* 0 Ooea-rtotponre MiWi-Z i'ur Lunt 0Crup4Urtn.il morality The very hich risk oi lung A. Iiunuluattun ennerr from exposure la nil usbeittus At ospl.iinrd above. OSlIA't fiber types support* ehyting the ime determination that eurremiy exposed PFL for ill filler type*. J workers face * grove risk of miiestoi- Several epi<Jemio!o|i gtudie*. related dieette it primarily bated on the reiuiiiui one performed by WOSI l raaulu of quantitative nik etscstment have found that worken exposed io t.ilc performed by the Agency. The process containing nbeitoi have excel* of (tuning the nek (rum eibtstot mortality from lung cancer and non- exposure includes tevarii tttpt. OSHA mali|ani respiratory dittos*. Slucy hat entleolly evaluated the tcieaufic other studies hove observed excess evidence eoeceroing the health nak (rum morbidity frooi respiratory disease! asbestos exposure. OSHA. * w ell a* cheat X-ray abnormaiilicv end lung other tcieaufic group*. believes that function deeramanta among tueh tsbettot exposure causes lung disease, workers. One non-positive iludy rtspirutory cancer, metothebuma. and conducted by atill* end TabewJuw of gittrotnieiunal cancer. OSHA hue also talc worker* hn mcthodologie examined (and discussed to the ucuon Unitauona auch that U does not refute atudiea finding txcttt mortulity among worken azpoatd to lafe containing asbestos. A naatber of atudiea m laboratory eaimala hive implicated tang thin entitled pid*mieJotie IvidtMt M Mjti from iapaiunt *t Cunwi the PL Section IV B.| evidence that indicates that axetu disetst nek haa been observed et cumulative exposurea at or below those permuted by the existing OSKA e-hour permissible exposure a abettoe fiben in the etiology of eanear limit, in addition. O&tiA hes made nek and lung filmeis. Stanton it al- found eatimetee ef axeett mortality (fern lung that fiber* greater than 4 wm in length eaneer. mesothelioma, laitroimestinal end 14 am or lees In diameter were the cancer and tnadanee of tbeetoin using meat carcinogenic however OSHA mathcmatieai medals that describe the believe* that Stanton et el.'a etudwa do data obsarvtd in eptdtmioiogic etttdic* not azdude the potaibdity of conducted in various industrial carcinogenicity of fiber* ihorter or populations. thicker dun theae dimetuioss. In many eaeei the elevated risks teen Canemr Dose response information for lun* cancer bated on the pni*mioiop-eul studies indicates that the nak ef itbcaiea-mduced lung cancer mereaH-t l-nearty with dime. Therefore. OSHA behave* if tt appropriate te use e muthemjtical model which assumes th.it the exeeti risk is linearly proportional to dote to tstitnstf the teem mortality which is suoasted with ubestos sxpoiur*. Thil excess risk is expressed ss the number ef tdditiensl lung cancer deaths per 1000 workers exposed for t specific time period. Excess nsk equal* the cumulative deie multiplied by s potency coefficient filupt ef the doseresponse curve) estimated from the studies. j.Nole: Total dost, else referrrd to as eumulativ* exposure or eumulattve dote, is measure ef the sneunt of tsbettot inhaled: it Is tht product of the duration ef exposure (in yetrs) end the intensity ef ex-posura (w hich is workplace sir concentration in mppcf or fiber*/ee). Under this definition ef exposure, a person exposed to airborne etbeaios at 2 fiberi/ee for 20 years ISO fibert/ce-yesrt) has tht same total dose es t person who It axposad to asbeatot at e flbers/ee far 10 year* (ao fibers/cc- yaarall. Evidence ef the linear dosmrttpens* mlsiionihtp for lung cancar ia found in At leeat 12 atudles hive observed in worker populations reflect past several well-conducted epidemiologic encase rtortslity from gsstroioieetinul exposures that were higher than that* studies that txaeunad lung cancer cancer (ttomach. esophagus. colon and permitted today. OSHA't quantitative mortality ia relation te the eumulativ* rectum] among asbestos exposed nsk astetsmant emails using the asbestos exposure in tht werkplxct (far workers. 7 of which found atalisticaily directly observed risks from these put txampla. Henderson and Enterlice. 1*79. significant nance Other eanctr aitea axpoaurea to estimata risk at lower Ex. Liddell et sL 1177. Ex la-U; have also been observed to be increased exposure levels. OSHA belleves this is a and Ocment et aU igg& Ea. *4>>:). In by dilfnent inv-igators. OSHA scientifically t'propnate and valid the three studies cited above, workpiece behaves that the positive hutoin studies procedure. In seme instances. OSHA asbestos air canetnirauons ware finding geairomiciiinul cancer encesiei estimated risks using studies which available from measurtmtms mad* in outweign the non-positive and equivocal actually obsc. .erfniki it or bslew the worksite studied. Although the arumal studies of ingested asbestos, as cumulative exposures permitted by the studies differ in the magnitude of the well at tha nao-poeiuve human studies. currant standard. Tha range al atudiea nsk found (discussed Istsr in the Therefor*. OSHA conclude* that excess covers many diffartm work situations section), el) three demonstrate s linear morality from gesirointostmal cancer and exposure Uvala upon which to bate relationship ovtr the entire rang! ei should lie included in qualitative nak the extrupoiut.eaa. Whore possible. observation. unult its for aebetto*. OSHA hus quantified the ranges of Other scientists and lotntifie groups Cieervtte smoke and tabes(os have a multiplicative jtyndfgisiicl effect with regard to (reduction ef loo* cancer. Asbasicsta alta might bo toenased in cigarette tmoking asbastoo svockant relative to n--.gmakag ubettuo worker* OSHA it **t w*n nf nny evidence foe to ofteet ef dgatrtte oinking ao hednetmo of atesothrluMMt or gastrointeaUnoi mairgnunnn* anna* usbrsint worker*. Hammond et ul. found thnt both smoking and nonsmokm* awbrsitis insulation wiifVrr* h.i n-lutive neka for lung cnnCrr uf ulsiui 1. uneartamtias in tha estimates. These who have attemptsd to estimate nsk naittncwl estimates, as wall es these < from asbestos exposure ksve ettd the risks observed at lew exposures, war* linear model for lung cancer tCrump. Ex. evaluated to determine the significance IML British Advisory Committee on ef the nsk and to determine whether the Asbestos. Ex. M-21*. Aehrson and tendard will lead to a substantial redaction m nsk. Cardntr. Ex. k-!tl SelikofL Ex. *2-2. EFA. Ex. M>taO. CHAP. Ex. 44-1MI The The aguttoni below provide a brief aynoptia of OSi lA'a quantitative nsk cxtinuu-t firnvrd from maihumuiteut maMs. A mure detailed dcserpium uf OSI IA I calculation* for .tdxwine. model is gmernily accepted and OSI IA believes use of the linear mode! for predicting lung cancer due tu asbestos exposure it reasonable and welllupponrd. retail'd banrrrs it m the puldie ducket Relative risk is defined at tha mtiu of * and i ivwituWe upon niquesl (F.x. * SB). " the mortality rate of exposed person* io the morality rate at rqutvnlant non- J 0 C 7 31 yP 0907195 DU 028296 Federal Keytltr I Vol. <a, No. 2ij / Fridar. November 4. 1083 / Kulct and ficsul.mom SUZ3 txpottd person*. htlative ntk it frequently approximated by the atandardictd mortality rauo IS.MX). which j ih* obtarvad number of dnetha in tha exposed popeiifca dmdad by th number a/ daetb* i|at would bo I expected in the eipoaed population. Tha number of expeeted death* :a utuuliy derived from the epeeifie e|*. te*. *d calendar year mortality rotoi in the companion population. Baaed upon the eonuderationt luted above trid on ih data. th rektue tm model uted by OSIIA in au<.inn| the nik of deveiopm* lun* exneer from atbeitei oipoiurt it dtscristd by inq faliowinj aquation: *L `*1 C' * (*t * f x (.D Tilt it. lL/c). . ^ * f * t.w (U. 21 Mr) It Uie tuny cancer aortaltt/ retvlttnf frea tlio noiuot txooture, It Ui tipoctM aortal tty tn t* tetanct of oxtoture, f it tno totoatUy of txpoturo in ftotrtrcc, it We duration of exposure' in year*, t It tne ttae from tno onttt Of Ui ttoottot txpttere in year* latnut lb year* to tllea for otnta.m utont pertoe) ana It tno preoortienaltty constant Wat it 4 Mature of tno carciAoqanie petdney of uic ttoottot tapetwre (tlooo of tno iou-'<i*aju< curvet. (for t aero total loo rttiontio for tno cnoico Of uitt OOOOI. too Ct. H-3). Tali calculation >ti oorforaoO for tocn ft eye*r aye tatorvoi; tno overall lufl| etnetr ritt it won coapuctt u tno lit of tno rtttt in oac* of tno ft*o-y*r intervals Irm tpo 24 to tic 70. Tht eaneopt of dirtei proportionality of tbt nta of Ion; eancot to the dote eon bo dtmonttroiad with t limplo oxample. Uain$ tuition t if does to mcroasad by o foetor of thtoo. toek it mcnuint tho dufonea of txposuro from two year* to tix year*. tho txcott loioove tuk |(KJ R.)- t|n*k incretaos by* factor of ihrto. Alto, reducin* data by redeem* ir concentration*. lack oa front 4 fiber/ cc to t fiber/ee. redacts tho noil relative nik by a Uttar of foar. |H should bo noted that tho wtMotao of risk |ivtn la Tablet Mood tl ora estimate* of oxcoto hak. aot txatta roltuvo rtak. Tkcrofort. ditact HMomaulity af daw m1 mk aa dotonbod obaoaaMy not bo ohoonredL. Further utkatM 10 airoa in Soeuoa tl C Xtow-*o(toao* ft*M fix Mesathehoma OSIIA brlmaco that the nak of attothclKuu^ ia beat rtuawlgil by an absolute riik aiodoL Abtoluto nak it eolculaiod tt (o j ,trvd dcoifctfportotw yean tl nik). Use of SMK't or ttiotivt ntk it not tpprooriatt for mesothelioma omonf t cohort of factory warkarx in Cntlond. Umtted date **t slao available from three ttudie* on the doie-rtiponit ralatianahip for meaothehame (Seidmta beetuse tho expaettd number of dri tha at *L W% Ex. W>C7: Hobbs, tt at. 1980. bt t cohort would bo dot* to taro duo to Ex. 131 (ltd lottos tt tl. 1MQ. Ex. *4- tho rarity of tho dittuo. ia addition to CMi- atinf absolute rtak rather than rolotiro Tho doit Indicate that mortalily from risk, this rdet it different from that itceothobomo btttnt to aicreitt only oood for turt eoneor bocanto both after o tniaiaoa af ton year* foitswmf duration of umt ataoo initial txpoturo and duration of txpoturo on tho initial (xpotere and baiina to dscniit tftor tS yoon from onset of determinative risk. The mafnitodo of the., exposure ISplikofT ct tL. lVff. Ex. oa-oo rftk ineroom linatrly with intonaity of and Nicholton at aL 1M3. Ex. 04-1S1). xpoouro. whartaa tha ntk increase* The mortality front mtaotholiomo can ba exponentially with duration of txpoturo dtunbtd by tha foilowui* epuauoni and time from ontot of exposure. (EtuoUont 3). The retiontla for such t modo! (nr doocribiat metothtliona risk bet been diocutiod by aovanl tuihon (Anutaie and OullTMt. Ex. ho*341 Pike 1000, IX-3CS). Such a modal wot eutised by Newhuutv und Derry lira. Ex. 00-M2) in predicant metothctioou atottelity J0C732 DUP 0907196 DU 028297 r tocro nc^iicr ,, 1 ' > til )01J . ' H, fee l 210-W far lua>i*IO **,, 4 f I far I0>l rftM It the aorwltty fra* tltlftthsM, I l| tM IM*H/ af tieaturt in ftctrs/ce, n in* turitttn f tiiatwr* In y*sM. l it tiat liter firtt iimum in r**r, w >, n tM *r***rtl#el H/ cent tint tnet it Miwrt *f tn awwlMliem* card nagen t< sottnc/ (|I*M *f i n-'HMi urvt) (In. ga-lttf. D. OSHA'* Qutntitativt Aitk auppltmantad tha human data with AjuumtiU raaulu from animal atudiat in tht OSHA* critical evaluation of all relevant animal and tpidtmielagieai atudita maul ted in selection af eleven tpidoraioiogteai ttadiat far etlculonon if the Kt fee lung eoneor (Saiikelf *t *L in Ex. IMS Stidman tl aL in. Ex. *47: Hendannn and Entariiaa. 1171. EX. M-U H'tiiJ *1 aL Wt lx. H-SL FlnktltieisulMS. Ex. M-ifOt Pita. tNO. Ex. *4-100: Damant at U 1M. lx. M> U; lany and Nawhoita*. ins. lx Mn: Liddell at aL. }rr. Ex. 44-41: Nicholson evaluation of the htolth information and in tht datarmination of tht significance of risk beesus* OSHA baliavn that tha animal ttuditi provtdo valuabi* qualitative information on tabetic*- rained disease. it is not dear in oil inatancot whtthar laboratory aninuic have bean txpoaod to fiber ttsa diitnbuuont timilar t* (hota found in workplaces. In addition, aabattoa appaart to multiply Us* undtriytaf lung eaactr nik of smoking tad nonsmoking at al, ltm Ex. w-rs tad Kubiao at aL worker*: laboratory animtla generally * .1CT. Ex. M4i| and font far K ter oiatoiKalioma (Scltkofl at aL 1 71 Ex. do oot have any underlying nak for developing tuns cancor. However, tha *4-40: Stidman at al. 117*. Ex. M-47: animai itudit* da thow that til FinktUlaia at. at. 1903. Ex. 04-340: and commercial aabaata* typat can cauta Pats. 1M0. Ex. M-iM). In (taanL eaactr and pulmonary nbroaio. Aniatal atudita of human cohort! in the atudita clao indieat* that longer. thlnnar workplace thould provide a batter batia fiban a. y have grtutar eareinoganic for quantitative rttk population! at nak potaney than thort coart* fiber*. and tha populations from which (ha risk Tht range of citimataa of nak from the aitimiiai art dam-ed. In daiarminint tltvtn epidemiologic iiudiat ia rathar the ptttncy eoafficiantt K* and K Urge. The differtacoa in results among Equation* I and a war* aaad to deflat the atudita can bo txpiatntd in aevtraf the dota-raaponaa relationship ao that way*. Than appaart to bo actual cancer mortality waa aatiiMUd for different** in ntk depending upon tha vanoua exposure lavtla and axpoaur* otura af the aabattoa axpatura. One duration*. A number of walLconductad potential explanation io that werkpiaea* and high quality epidemiologic turdws differ with regard t* fiber atx* war* availabla that anatainedrfa/Cotnt distribution* (longer Oner fiber* appear Information on which lo baa* a to havo grotitr carcinogenic potential quantitative nak assessment. Soma af than tha esarte fibers L The observed K< that* atudita did not cantata txpttura value* for atudita of mining and milling data, but anuld k* coupled with operations, whtrt airborne ilbert era axpatart lafanaadtn from tthar taureea relatively coarse, are lower than tha Kt in ardar ta ebuki an aatinuta of K*. and valuta found in studio* af ttxtilt K* aperuttone where fibers ere (tne. OSJ IA cheat net to no animal ttudiao OifTerencu may also be explained by to predict quantitative estimates af rtek the vanauona in study design and ether from asbetto* exposure duo to tht many (actor* influencing tha ability to detect high quality huaun atudtea that cxitt txceta naka. On* af that* it tht iimitad that wi-rt conducted in actual * knowledge of putt fibar axpnturea of workplace eituanone. Rather 0*1 IA hue ihoao population* wheat mortuitty waa later evaluated. Prior ts 1*70, few meeturementi were mede m tecliiiei uinj tvbetiot fibers Further, ihsie meaauromantt that wart dent usuaily tuaniified all dust preitnt in tht workplace etr end not juat fiber*. r Current technique*, which involve u*e qf mambran* filler* and phase eontruat microecopy for the daunting of fiber* longer thaa fiva mtcromaitn hsv been utilised Ia Cryst Inlain and tha (Jetted Stttaa only Lae* 1PM (Aytr tt *1. iici. Ex. **-133:) and havo batn itandardizad ia the United Stales only since i*7g (LeideL 1*71. Ex. 44-42) and avtn later ta Crest Intern. In any eaae. samplm* has occurred only for few worksite* and than taly aeeasionelly. OSHA has evaJucied tkrse differences and hava danit with their impiicationa on study by study basis, at axplatnad in the quanutativt riak aatessmtnt (Ex. **- . MIL OSHA aataa that, despite theta apparent limitations, taken a* a whole, tht tsbeiioe atudiei contain data af unusually high quality which he* tnabitd OSHA to mike the nik estimate* with a high degrte of confident*. In addition, variability in week activities and in sampling circumstance* add considerable uncertainty to knowledge (dot*. Soot* it the tpidesiiologie studies, indudiof those by Oaaont el *L (Ex. ta li). McDonald at *L (Ex. (4-4IL and Hendema and Eateriine (Ex. S4~t*L kav* moastrod elr coneentraeoni at tht sxposuro tit* and ustd job histones of tha study population to tstimat* txpeturo. In thss* eaitt tht dose* rospons* carve wot calculited by estimating total tsbostot exposure (in mppef-yetra er in fibar/ee-yearsl tccarding t# the time that an individual pern at a fob with a measured exposure value. A eonvonion factor for convening from mpief to f/ce waa employed oa * study by study basts depending upon tk* dot* available. Oinst apidomiologieal itudtai. for example these by Seitkoff tl ai. tEx. 0^ (OL and Seidmon tt si. (Ex. *4-47). had neither job histones nor direct tndustnal jtygion* aieaiuremcms for tht studied worker population. For that* studies, expotwr* eiiiault* were denvtd from induatrial hygiene surveys of similar woek apertnon* and practssai for which industrial hygiene data wtrt available. The otudy by Stidmta ti at., hawsvtr. canuincd toed information ragarding durulia* of exposura (which exa often be examined at a surrut-iie for doit in estabtiahuig tha shapa of tht aapd(ur*<m*po*M relationship). jjamiafed in Section IV. OSI IA h* canciutiad that workirr* vxpoacuTa J , r 7 DUP 0907197 DU 028298 Federal Kecitltf / yai. Nn ; rdrf*y. November 4 19C / HuIm nd Kguijiion, 51U3 tibjllM Iff likaiv >o be ii n BiTellaiirntnitlimai cancer.TTKaugii in axcsaa efCI uncsrjiasnot bean _ eKiervtd eenaistantiy in Tvafy'ifudy af aiiettoa worker*. and whil the ratio ef inwin(MtmjL^ne#lolJifeii(eir vatii eoneider.qWyJJm ygdyjottudy. thara appears (o b* a^ifiefaat ayidiinea U roughly eijjmAtl_Sbqj_xcji|__ littrotataattnsl cancar nit In isbostot- cxpoecd Miulatidhl. In atnerit.~Pta~KIlt rvtaas from about i Id OTiT-Sl uctt'l finf c**ir rtak. fA detailed table aUiM STkiram goitroimeiiinai eaneqr ogggtue'JT etudie* (jjivpn In Ex- *- 182). Is aa-ttempt lo quantify til nik of liftrointiitlnal eancir. OSHA eoniidan that i simple riik model in which tho lunj cancer ixcitt la multiplied by 0.1 (10*) ii appropriate for woaiatingthe risk from gseiraiaiffsuail cancar. The aatifflaiaa of riik from gastraintoatinel cancar in alio given ta TaUoi 10 and n. Cancan at iltia otbar than tbo lung, mesothtlium. and gastrointestinal tract have ban thews to bi ilavatad in laso album sxpeaun itudioa. Including laryn|aL kidnap, pharyngeal and buccal earny caacar. To OSHA. it appaan that the excess nik for "otbar cancan* ia about tba saat aa for gutrauttettina) cancan. OSHA ncofaoci tuny uneartainUai is quantifying tbia riik. ia mow of tko taaoaiictaaeiaa ia finding* amesg different opidamiolo|ic itudioa. (Soma iiudtoa have found axcau riak boat otbar cancan, white otbar ttudiaa havo not) Tko itiaa thawing oacaai risk hovo bo varied among nudiaa. Therefor*. OSHA hti not mado nunancal actimitos of ritka far theta otbar eauaaa at thia ttaia. The data indicating laitrointattinai cancar exeat*** art etranger and aiaaa coaiiitant than tho data ieggtitin| esccii at thata atbar caacar litaa. OSHA daaa not faai compelled ta auannfy this ttak at thia time. Tka hi|h aaality and wallsupported aiuoatca af asaaaa nik at aionaiity fron tuna caacor. moaothoiiome and aalwftotie aiaaa pramda auflicuM buioa upas which to {uitify tbit actum. bliatott* tf Ca&ae Mortality A boat ritiaiato af K| waa eaJaalatad far oacb of tho ohwcanndrmaotaglc Studies ood os rotasaUt of K wat cakulatcd from tour of tbeao etudira (MO Tahir I) tKv (O-J02J. Far me* study. tho brus euwoale fur K* and K, ia Indicalod aiuoa with a ranon ai uncertainty. TV romr* fntn) anr fhuao an the fraull ui <->tu*trv uf v\puaun tmcertaintUK |uuuil\ a tonor of 3). mettxaliik'v-u -I >"' .uijurtun llwi led lo allcraji'1 w.iluaiiuna uf utk u vvjHwura ar ta ioa eaiaa. itaUiticai anconiintici auoctatad with mail Humbert. Oatailod dtrivation af tach rang* of uncertainty ta diicviaad in b. srlthmatic ind etometne aaanr of iheie rattoa mix lO''. Thai. \ x is** n in ippmpnite cheiet n the bait iinmstt if Ka/Ki. tiling Ifcn eitiruii af the ratio ta-ML Ka/Kt ind tha prtfintd (inmate of Ki, Tko diitinct ttaturt af eiimtifanilUnf data (and banco, tba estimates of IQ fron these data| Hava barn eonttdend tnriisr. Than u tamo tvidonco that (OJl). tha pnfitrtd iitimatt sf k'a ' would bo 1 x 10** (K.w i x 10"* x l x 10**!. A rangt af 3 x 10** ta 3 x 10** for Ka woold appropriataiy mpmtnt riiii ia tbo iiboitoa mining-milling most axpooun situatieaa. operations iro lowor tbaa otbir Industrial ipontiom dua to difftrtneaa fat fiber mo. That, ia determining tba Then ia ao ovtdsnea ia thia analyiis that would suggest that a tpaaal lung caacar potency ia ucrbabla to a bait ivinll value far Kt fron tko ilovon apoctfic typo af fibar. Soma af tha studies, tbi dan win ixominod both highlit and toweet values far tct ire with ind without tbo Ki caiauiatad frets obtiined from pum chryianlo expoiuras tbo itudna af ettaing-miHIng procaaaai. (for example. Kv calculated from data af Tht nn|a af individual valuoo for K| Dement at ai. is <3012: asing data from covin two irdan of atagnituda. (rots Fits at oi givta a IQ cf 00071). oaeoa to <UU. Tka aritbiaatic miaa af Cxpoaum involving a mixture ef fiben. tht lavan values af Ki (unit mb par f-y/ Including amtiite and aoadolite. ilio ccj ia OOPSl. and OfSCr whaa tbo K^'a pat a large range af viluw for Kt. front mininf tad atiltini an anciadod. Wide diffotoncM also eccw ta tho Tho laomttnc tntaa of tbo data ia 0007; teauita af aaparata aptdamielogical whaa tba tatiaatot of Kt from atining* itudioa tf almilar work esadi&ani. nUlng oporauona art aseiudod. tba Soma actamiau havt luggotad that Moaotnc auan af tha K^'i it OOIU. Tba isma aaboatet procaatoL such at Kc'a havt a sadiaa of OOOS1 with tbo aabcatoe testila manufacturtrg. may atinin|*tiiJ!utf procoatoo and madias of 00131 when to fujung-ouiUnj poae a graatar haurd thaa othar procoaaaa. Far nampla. aunuig and ptoctaaoa are aseiudad. Conaidanng tho iadtutrit! proeoaaoo milling spptars ta pa<* Isssar carciaegtruc hautd thaa manufacturing otbar than atialng aed aUlfini. OSHA Moaaaaa. OSHA ecaparad tht potincy boitovoa 001 to bo a naaosaala tactara far famg caacar (XJ among ooUisata af Kk. It k tho iooaoMc moan difTarunt apidmnieloty indies af tad atadiaa of tha K^'a darivod from aianufaenotng procataat bocauaa tho ' ttudiaa of aaboatos auaufacturino tad potency factor* art bated ta nsk per insulation applicatios proctaaca. Tha unit dflM. Ho consistent pottam of l Mtutnc mean baa tbo advantago of dilTanntial lung cancar nsk (i.s. higher Buniasmna tba infiuaneo of outlying Kt't) by proctu emerged. One itudy of veiuee and a Kt a/OOt la appranimaialy eabeatee teatile werfcen found a very wtthin eat ardor af magiutuda of ail tht high hah while another found a much ootanotoa of K^. la tun. tho K^of OOl ia lowar risk, and tha tamo was uut tor a ban at matt which contain! the two atuditi of aibaatae production apprepnatt recognition of itudioa with worker* end the tw# itudiea ef iibeste* higher and lowtr values of Kv It ihould ettnant woekara. Themfor*. tha choice of bo aatad aowivag that tbo uneatuinttoi midpoint wtit risk for all industrial around tbii aatimato of iro luck that, ptoeetsas (Ki0Ol) ta a reaaonablt and aa appmpnata aatimatt of K^eauld Uo tntifiodchoica. borwten 0.003 tad 0^3. Tko ba*t teUretiee af Kt and K wara Tha oittmatos af Ka givon ia t obit IS. .Uixad to aeUecati tha mortality from art darned barn studio* with four of tho txpoaarti to veryiag eoocantrationt af five Ughoot Kt value*. That la. than ia ooboatoo far difftrent time paneda omo biai iu tuauniai tho value af K* baginning at diilartitt agta. Tka Indopendtat ef the Ki in the lane ., calcuUuona art ago. Intaneiiy and tiudiee becauae ii ta likoty that time Ka duration ipaeific. Tibiae 10 and 11 iltow would tend to bo (tightly lughor thoo tho oactu aibaatowraUted mortality theoo derived from ether studies, duo to rate* from lung cancar. awsathalienu. the domanatnted high power of those and lastroiatoatinil canctr ittediot to detect nik. The iritbmitie (gaatramttttinsi caacar txetas it Oman af the Ka'i ie aJt KlO*'. and the aaaamad to bo 10 parcent af tha lung gcomatrm attan af tha Ka`s la LSI X10**. eancoe oxen**). In that* calcuUuona. Ta tecaunt for some of thia bioa when Equation 1 and Eguauon 3 ware ueed eidfiMnftf K*. it u useful to uamata tho ratio af Ka to Kv For tho four studies tot which Ka was coiculatad. the rang* of the ratios of Ka to Ki it only twe*fotd ' (fruat a.;s x to*' to l.rx 10*'). Both tho with vuluoa af Kt equal to OOl and K equal to 1X10-* and the itn VS. mole backgeound lung cancer mortality ruiei Ooeause of agt-specific meraotea tr. lump cancer raiaa ta alder men imee 1UT7. j:C7*7 iC L DUP 0907198 DU 028299 51128 Ftdoral Repittor / Vol. Sh No. US / Kriduv. No^emhrr 4. HB / Ruins and Regulations estimate* based on moro meant buckgreund ruu-s would b<* higher. Calculation* were dan* tot tueh i-ytar age interval. and then rammed to give tout Ufctuno ruk. Tho cslyiettona performed to giv* th* rastmt in Table* 19 and n ettumed that th* rcfaitvt nk incrtaxed following tea jrtlrt after anact of aapoaui* and eorMinuad to rtso until tan years aim amotion of t>|oiutt. after which it (trained totutoni. Tabla ]0 giv*s sstiaiatas of nak for one yew of axpotur* to asbestos at various eoncantrauont for worker* beginning txpoturc at ages 20. X. 40. 90 and to. It thtuid ba noted that tmpfeytt* aapoaed at aariiar a|t* thaw htghtr rttk of all eanr.ar* due to <ha lonj period of tin* during which It will b* poMtbl* for diaata* to develop. On* year of axpoaute to asbosto* at 2 (fee starting at at* 20 ray raaoit in a total txcttt eancar nak *f 242 par 100.000 worker*. Tabla u give* the predicted aacaaa lifetimt risk *f eancar for attpeaaraa of on* year. 20 year*, and 41 year* aisumini first expottir* at age 2S- Saver*! eeaunenu should M rad* regarding th* results in TibJ** 10 and ~ 11. Though aacaaa ralativa risk is linear in do**, tha exeat* atonality nta* given in Tabtaa 10 and 11 art not itrtctiy linear do**. Tharafarc. for example, th* risk at 2 f/cc ta tut txacUy 4 tuna* o. he risk at 04 f/ee. though thert is * Cloat approximation. It should also b* hoiatl tftut the twka for longer peneds of atpoauras do not apxtr to b* a airtight-forward multiplication of tho naki of ahorttr duration. In tha longer tipoaurts eeitgonct. where axpoaur* wtU affaet older worker*, torn* adjustment! hsv* bean madr for eomxitng naki whleh are likely to affaet th* death rat* from lung eancar. In addition, whaa looktni at tha total eancar nak*. it rust be remembertd that these include the risk *f meaoihebora. which ta related la Um* in an exponential fathian. . Aa can b* aat* (ram Tabla 11. th* predicted nak from maaathtlioma to approximately equal to th* June eancar risk for on* yaw of txpoaun and. shout onadulf th* ruk value far hint eancar In tha 20-ytar axpoaur* group. Tb* iieau risk of maxothafioma after a bfatim* axpoaur* 141 yatrtl to atbattos is approximately ona*third the bfatim* axe*** lung cantor nak. Thaa* predictions comport with observations in savaral population*. where marubty from tsotltaliom* is observed to eonpria* c?p* - inly H percent af th* txcaaa martality tram lung eancar. Using th* aquations fives aariiar. and bawd an tha calculations m Table ll, OSHA predicts a lifttin* aseais risk af tata) eancar for a Uittiaa axpoaur* (49 yrtnl to 2 f/oe aa Kit cxcasa deaths per 100.000 worker*, or approximately per 140U. Recogniang that a 90 ye.ir etpoaur* to aabestot may b* another approaintatian af actual wrkar axpcnenc* of iataraat the model* prediet so t'eati eancar martality af 4JA2 daaiha par 10(1000 workan. Reduction in th* PXL fram i Hot to 04 f/ee reduea* th* risk from bfatim* rapoouro from M par 1.0CC to IP per 1000. Similarly, far a 20 year exposure, th* risk i* raduead from 44 per 1.000. to ti p*t tAB. repmantmg a Tt% reduction m risk. Tha bfatim* risk from on* ytar of axaaturo foliawx * similar count. Th* risk reduces from 2M per loaaoo at i U ce. to 74 par 100000 at 04 f/ac. Aa dtsmnaad above, this impiitt that th* Ufaiinw axes** risk from a six* month axpoaur* to ttbettas wauid ba approximately 1M par 10(1000 at 2 f/ce. and 27 por 100400 at 04 (/. Uatly. Tabla 11 contains ih* risks for (avals higher than 2 ties, bacaus* OSHA baiiavaa tom* industrial area* (such aa construction) may b* at Uut* higher lavtls. This popeislion of warfcors would eaasaquaotly axparianea orarh grratcr reduction I* nak by axpoaoro* to as f/ocorltt*. XiM*OKM 5 DUP 0907199 DU 028300 fdtrl g^:ier / Vp|. <g. 21j / Friday November 4, iwj / *uio\ and Arm Ttolt Estiotttt of tnt Sloe* Ptrwtttrs ror tun? C*flcr i*u tno ***etnl10a* oy Process Study swnufACTWtWfi f o k* Asbestos Products HMtdtrson l Enter line (1979) 0.0047 (0.002b - 0.006b) Asbestos Cement Products dtill tt *1. (1971) 0.0033 (0.0016 - Q.0066) flnfcelstein (1933) 0.067 (0.033 - 0.13) 12 (4-30) Textile Products Ptto (i960) 0.0076 (0.0009 0.023) 0.7 (0.3-2J Otmnt tt ti. (l9tt) .042 (0.023 0.21) friction Products terry 6 Ntuneust (1963) 0.0006 (0 0.004) Insulation Products ( Stiddun tt *1. (1979) 0.063 (0.0049 0.14) 6.7 (3-11) insulation application ielikeff et ti. (1979) 0.020 (0.004 - 0.030) 1.6 (0.4 2.4) HININ6-M1U.IN6 UddtU tt *1. (1977) Nicnolsen tt *1. (1979) Audino tt el. (1979) 0.00066 (0.0002 - 0.0011) 0.0023 (0.001 0.007) 0.0061 (0 0.009) 1 Vtluts in ptrtntntsts rtprtstnt tnt rtnq* of unctrtunty sround cm utiMUt of k* and Km- Thtst ft cenputtt en study ey study otsis tno calculations for ttcn study <r discussed in tnt ttit. ' VSji4l 1.79 0.92 0.44 .75 DUP 0907200 DU 028301 S11L8 fdrl RcyisU-t / VbI. Ah. No, 21$ / fntl-iy. Novuwlmr . lfmn / Ru|eJ ,m<i Reuuuuni TaOle 10 Estimated asbestos rented exrcer mortality from a one year exposure to various user csncentrations Asbestos fiber concentration (f/D 0.1 0.2 0.S 2.0 Lung nesotnelfoa . uastromtestinai Total 7.2 14.3 36.8 142.8 Ace at first exposure: 20 9.6 18.9 47.3 186.7 .7 1.4 3.6 14.3 16.2 34.6 tt7 346.6 0.1 0.2 0.5 2.0 0.1 *0.2 0.5 2.0 0.1 0.2 0.6 2.0 0.1 0.2 ' 0.6 2.0 7.3 14.6 30.3 144.9 ** 7.1 14.1 35.3 140.9 6.1 12.2 30.4 121.7 Ace at first exposure: 30 4.9 .7 9.8 1.4 24.4 3.6 97.4 14.5 12.9 25.7 64.3 266.6 Aoe at first exposure: 40 2.1 .7 4.3 1.4 10.7 3.S 42.6 14.1 *.9 19.6 49.5 197.6 Age at first exposure: SO 0.7 .0 1.5 1.2 3.7 3.0 14.7 12.2 7.4 14.1 37.0 14o.6 4.0 8.0 19.9 ' 79.6 *oo it first exposure 0.2 .4 0.3 .6 0.9 2.0 3.4 6.0 60 4.6 9.1 22.8 91.0 Estimated os 10% of lung etncor risk rather than calculated using dose-response information. rL>1 nu "/ 7 7 DUP 0907201 Du 028302 reaerai / voi. <i rxo ,15 \ rno.*y. .*ukvn*`wr v T tbit 11 Estimated Asbestos gelxtea Oncer uprtxMty per 100,000 Ox Hunger of Tetri Exposed tnc Exposure ut*ei 1 Asbestos fiber concentration lf/al) 0.1 0.2 O.S 2.0 4.0 s.o 10.0 0.1 0.2 O.S 2.0 4.0 . s.o 10.0 0.1 0.2 O.S 2.0 4,0 S.O 10.0 Cancer mortality /IQO.OOO exposed nesotne- ------. lung Jiooa Gastrointestinal2 Total 7.2 14.4 34.1 144 288 340 715 13? 278 692 2713 $278 6509 12177 231 460 1143 4416 8441 10318 1851$ 1 year exposure ` 6.9 13.8 34.6 138 275 344 684 0.7 1.4 3.6 14.4 28.8 36.0 71.S 20 yeer exposure 73 144 362 1408 2706 3317 6024 13.9 27.8 69.2 271.3 527.8 650.9 1217.7 4$ yeirs exposure 82 23.1 164 44.0 407 114 .3 1SS4 441.6 2924 .844.1 3547 .031.8 6141 1851.5 14.8 29.6 74.3 296.4 591.8 740.0 1470.5 225.9 451.8 1123.2 4392.3 8511.8 10476.9 13996.7 336.1 670.0 1664.3 6411.6 12209.1 14896.8 26507.5 1 Assumes eipesure Begins at age 2$. Risks ere calculated using U.S. mala lung cancer Background rates for i77. * 2 Estimated ts lOt Of lung c*ncr risk rather than calculated using dosaresponse information. DUP 0907202 JGC73S DU 028303 *tfit`g;riWsrli*e*ifc|.i'i*i"ar'r*'ii............... WW sjno federal ReiislOf t Vol. art. No. 21S / ynj.iv. Sovrninur *. f Qvonofywx (he fieri* ftt** f'mni Atbttloiu Mny studies have found the EonmaitjTum lung ducate. aalicstocis among iibcsioiexposcd wurkari. In feet, early occupaitonel h4ilth standard* governing Itlxjksi exposure pnmanly sought to reducethe incidence of tsbcsioait. Aabcstaai* te type of pulmonary fibroaia diagnosed on the bam of a history of axposur* to 11betloc it It chsracttrutd by radiologic change* to id* lung, bfcethietenia*. impaired lung function, and other dirties! feature! of fibroalng lung dictate. Aibettoaia can be manifested in a range of detract of teverity and can fttult in diacbtiity and death. An aarty retponia by the lung to aabeatea exposure u formauon of plaque*, which art opaque patchee visible on cheat X-rays. The pretence of pitquet might indicate tnereaied hah of future development of atbottoaia. but this la iot eenain. Although the diaeaae aigniTtcance ef pleural plaques is not eitar. the preaanct of the plaques it aot normal. * Sorry tt ti. (1IT. C*. M-201 deftace AsOnsiuait h.<* hern known m ftntrvtt or worsen after ceiaunon of exposure, proh.ililv due to irreversible Injury and/ur the mention nf ahc*ioa fibers in the lung in adtiinon to lung function impairment, iibuttnsii contributes to inrrensed aiucstosrtfaitd mortality. inerteed rusieiuflec eresied by tha lung obsiruetion can lard to hear! failure. lecture of the many poaaiblo defmitioru of trbeatoaia given by different groups, ih* quantification of a single risk asiociattd with tsbesiosit is difficult. It tt elcar that material impairment from asbaiioti* occur* prior to the onset of its disabling stage. Quantitative studiss tain, primarily for tha disabling forma of the disease: specifically, twa separate studies provide informtlion to develop a do**response relationship between asbestos exposure and incident* of tabaatoaia (E*. M-2S and 14-44). Two dofinmoas will bo helpful in interpreting tha data concerning tsbesiosit. Incideue* it tha rale at which new cases of atb* .on* develop in * given period ef lime. It la a direct measure of the risk of developing the been calculated from incidence dutu of two iiuOiv*. Ocrry and Lewinaahn iF.v. M-25a| and Finknlaiem (ff*. Q.| u). OSI1A Iws alto txammcO prevalence rates 10 support a quantitative assessment of nak fur a*bc*o*. and theta dais will be discussed first. ' Berry et *L (1CT. Cx. *4-20! Kudirii a' group of Iri men who worked ct an itbcaiot tcxiUa factory for at letat in years Oust measurements wen available and wart comlatad to tech job performed for taeh year under study. Health affects were corral* (ad to cumulative exposure Table 12 shows the observed prtvtltne* of crupuetiont. "possibl# ttbottotis~. and certified tsbtstet for data from Berry et al- si taken from the fitted curve in Figure 4 of their paper. Possible atbetloti* was diagnosed by the factory medical officer if he thought that a eian was dtvalnpmg signs *r symptoms of early aabcstoaiK Wtl af the mail diagnosed with possibl* asbaiioti* received certification within the U yean following this diagnosis. Tha reeuit* in Table 12 represent a group of workan employed after JIM. who bad a relativity short duration of follow up (raaximam interval from first `feasible tabeatoait' at a king -- disease. Os tha ether hand, prevo/enc* exposure was 23 years|. A higher condition berad upon wgna of tariy measure* tha number of cases alive in t percentage ef sabtitesit would moat tabeatoait. Ha classifies "poaaiblo papulation et a given period of time. likaly hav* been sbtervtd if the follow tsbettoiis* on the (biding of baiol nlta Numerically. It equals tha turn of all tha up period in tha study had bees ea crepitation*. radiological changes of inodtnea cases in tha paat minus all the txiandai. etrying deprt*. a faOine gat tranifar death* that hava occurred in ptopia who TI* observeliens of Berry ot al. factor, and reitrietivs changes to lung had davciopcd tha disease. Prevalence presented in Table 12 are probably voiumt or veniilatary capacity. Tha dafbiitian of atbottoaia verier among ean be reflacitv* of eaitting nak for nbaitoais in a population: prevalence undtrtttiaain of risk. First, tha nak shown is Table 12 dog* not give tha different investigator*, tarry et el.'a however, can be high for other reason*, probability of developing diseas* after definition of possible asbeatoaia. far esample. it nottufficient for the victim such at increased survival. Motaover. incidence ttubilahea a time sequence exposure has anded. out raihar. reports tha diaaast found at on* point in urn* to qualify for Onbah Oiaablamant whareta prevalent* looks at bolt causa Second, the data includes soma worker* Benefit tad effect simultaneously The best who may not hav* been followed long Asbeatoaia cat pragma to < disabling (sumatas of risk of atbaatosit have enough for tabosioaia tappear. condition where active work ia no longer poinuJe. Although no single definition of disability exists, venous 4 TAIU 12 government* have adopted definition* of atbotiM diaabiliiy to administer their worker's eempeniaiien laws. Finkelstetn ettvacCkCt or ewrraTtexj, oosstiu asusrosis mo ctxrimo tcpUint the aysttip used by the Ontario Workmans CompcaaaMa Board: sutrfiii ron cimmUvC cirotMS to sutos Warkera lulanittm* afeMa* so dm Camiwntatwa toani <* eaaaiineii by ito urt at al. imtl Advisory Gemmate. hk ilsmwmmnlc wtwihrr or acr a Dwakitoy PeiHa* lie ivaniad. There are us smu ojrena fur the Cic*>*ti *e*sa*.-t,i*4*/tc new swarding at a OiscWmv Ptamcs fur aabcaiaM hoi same at ike femur* mmitirad melada a homey af ~*lnon~ taooeort. a htaiery af dyaerm. dw pw*race af rrrraMwae er ehddiica rwlnwanhic cna af pulinnary hhmaw and dmnrmil pvlniucary fund-- imki (Kv **^a. * CWM. Peccant ltn cmciviaa t 10- CMiHinmt J2 M 'mtelt is***satis <1 14 Mg 1J* Cant'f1*0 asatsiovit SI 100 1JO ia f DUP 0907203 j~ ? DU 028304 ieMO*rHriaimfiis*eni.etixiisaW These d.tl* of Berry t( al. drmonlf.n* kcmal fk-xturci ofhr n.iture of the aioeitosit n*k. The d.iU ehtiw < continuum uf clinical response user th rne of doi>: that it. these clinical obaervaiions support ihe existence nf dese-response rtlejionship Scrond. i nett observe noniaiso support the existence of lo*' or possibly mi. threshold foe asbestos'*- since them n increased nek t< cumulative exposures as low 3? fibcr/ee-tearx. Berry end tewmiolm (tar*. x. 44- 2J4) hjv reported the incidence if sibcitcsi* m this tame asbestos textile factory Them data are prremted m Tltle 11 A dote response rvLi.orir.tu it apparent for the incidence a..t.i jm u It not quite si consistent for inc presalcnee dale. Table 11 incidence af Font*!* iteetuttt o/ Cumulative xpotore lorry and leinsoni Cwaulaltvt Expoiurt (fiotr/ee*y**rti 2 Incidence First emplojxwnt Ufar* tiki After like 0-4* SO-** 100*14* ISO* If* 200-24* 300*34* 3 2.4 3.* v 4.2 4.4 0.4 l 2 Fiakeistem (19C.Ex. t-ta) looked at the development of eampensauie^ (certified) ssbeslotis kmong 201 worker* el an sbeit#s<*ant feetory in Ontario. A doat-ntpoait relitianship wee develcned using eetinated eumelative exposure* baaed on plunt dutt meisuremems end wing medical information from the Ontario Workmen e Compensation Board. TebJe 14 thowt the incidence of certified ttbettaeic ceiei ee e /unction of cumulative exposure from the Flnkeittein study. TAHE 10 IhClOEKE OF CERTIFIED ASSESTGSIS AS A FUhCTIOh OF CtihUUATIvC {XPOSUAE FttatELSTElk (1912} Cuiulail** exposure fleer-years/ce t locipence 0-4* SO* 9* 100*149 iso*m 200*24* 0.S 3.4 74..5* 14.3 Flnkelttemt (19021 obeervntion* me* eventtatt the itvpdtace oi asbastaxu because at tutopey. then wee hsaiologie tvndcnee o/ ulieeete ee welt at ibtttoeit in tunymett- Kinkriitetn ttxict that "we hen. nevertheless, ehoeen to celt their disease iibcxteaisee we bahevx that it the *athoto*ie procast ol moat significance. Moat of the purmckymni radiographic ubnormalittet were email heugider opneitie* ttnd the mon.ility prilum among the men we* eontteicnt with Ihc toxic efireta of rsheslos.' On the other lund Finkelitcin't ttudy tnny huvu , understHted eibcitoet* nik by examining only certified diaudibly from eebeatoei*. which ia n advunetd etag* of itbesioiia. OSUA'e eetuMiea of risk war* derived from a simple linear regression of tlio incidence an the midpoints of the cumulative exposure duia of Surry cod Lewinaohn (Table >3) und Finkslsiem JTubl* 14). A lincttr relationship was assumed. el le.ni to ilia point extimMiion of 0.S kbert/ce for 41 yean Or 22.5 fiber ywrt/ee). Thu tuumpuon it consilient with the (act that tsriy states oi diesel** ere observed at low exposures. A similar conclusion it drxwn m the report of the Oriiish Adxisery Ccmmittci on Aebeitoe (Ex. *4-218. volume t p 20k The present eutharx came down m favor of a dune response re'enunth.j without a threshold for ch*yon'.i- wi.r the range experienced m industry DUP 0907204 j r * " / n DU 028305 51132 Federtl Ritter / Vpl, 45. No. 2ig / p>,<<3y. November 4. nu3 / Rylc$ and Rrgmqtior.s IU It tniwrti or uriTix iutsTosn kikku (mature level. 1 laer/cs 34 1 J 1 M 1 Isoeence 1h ftaaelttem v 1.44 l 2.41 4.If 12.43 24.M (err/t first a*t*r*dt efer* tfti After li O.ti 8.J* 0.11 9.11 t.fi l.3S *. i.i) 1.31 (43 Slope 2 - O.OM S.lfS 0.U20 .Mi 9.0U .MS The results oftteh of the ngrtsiion environment to (enereie cuantitativc analyses and prediction* of incidence estimate*. Animal studios art used to forMvtral doM eonetntntion* iro only lupp-r* and justify methodological givtn la Table 11 At (hi* Ume OSHA procedure- end assuaiptiona aiaktt no ottompt to extrapolate tho quaiitstivoly: For hint cancer. seUatista data uifl| thii nodal below tho Out |0'.*aUy accept the itneer modal fiber/ec lavti or above 10 flbar/ee lovoL fr'itint tnereeeed asbestos exposure to Tbo cjtimatet from the 1 cohorts differ - nek ond generally accept tho lack cf c by an approximate factor of 1. This may threshold. As stated by tho IriUak bo indicative of tome of tho Advisory Committee on Aoboitoot "Toe methodological issue* roited earlior. It la lung eaneer. tho ovoiloblo dota in man. pooaiblo that tho tstiaatts made from all of whieh sro derived from industry, Bony and Uwutaohn'e data may bo show an Ineroait in risk with ieertasini nnderor innate*. Tho maximua duration doe* af dust and wo find no evidence of follow-up m that indy wu 23 year*. ,, within the range of dust level* studied with an evertpt follow-up of II year*. for threshold of dost below whieh Observations torn Finkeisteta's data there is as tvidonc* of risk ' (Ex. P0-21S. (hit Table 1| domoaitrato that oaly til p. (!} fat tenoral, all tho ruk (23/M eaM*| of tout inedtact woo issasments uo cumulativo exposure so exponeseod m tho firm 21 run line* the moosuro cf expeeun for til unear flnt oxpoevra. That Is. M* of tho risk estimates (cumulative expoeura ubootoiii Incidence wo* not oxpraotod *ualing intensity times durntices of antil at toast IS run from lint exposure). exposure. Tin*, it i* likely that tha low Civen the uncortalades inherent in Sbtcidteee ratoo in tho leery aad Lewtruoiut etudy (and ihercfora. tbo lew etatitetive risk eiseseaent. a* well ee ie inevitable venation* in findings tollman predicted by OSHA) arc smont tha many epldemialofie ttudiet. reflective af the ehort follow-up period OSHA believe* that the different for thu group of work-re. quantitative ne estimate* agree OSHA boliovoe that the boot relatively well T*e venations that do eotimi'M of tho incidence of ttboetotio exist can bo axoiainod by tha eta tfaota derived bom tha Finieletein assumptions made or ty sunpla data. They indicate that among worker* methodological difference*. Some exposed far a lifetime expoeura to I f/ce of asbestoo. approximatoly II will develop a*bestoet*. Reducing thii lovol venation* may be duo to differoncox In tha work oftvironmtnt used m tho saaasamtnta. lo 9J lice would reduce incidence to For example. Crump'a aiaoMtaant. 144. It ehooid bo notod drat thoaa risk estimaiee roprettnt mddonee of ghrea it testimony to the Ontario Royal Cammuuoa on Asbestos tn August ditabiinf aabcstooia. Fim etgna of odvorao pulmonary effects are reported to occur ot lower Icvok* G. Othtr Qu&UHatirt Kith 'AtteumenU 3M3. contains quantitative estimates of risk for several studies, ineliding nooking-ipacific risk estimates. Crump does not pvt a beat animate of risk or to overall risk suntie. HI* estimttot of Since UML tevorol odoatiito ond eoefttifle oomeMWoo have ootiatatod risk associated wtth aabostoa exposure. (Cxi. **>1. PM. Ult S0-2M.J Tho ri*k aiuunmtt are in approximate ' risk art based upon an assumption that worker exposure that would result from etandiird set at a 2 fiber/ec limit ft actually much lower than 2 fiheta/ee. That it. hit risk estimate under a 2.0 agnement. They ail tat cpidumielogical fibert/cc siendani assumes that average ttudiet conducted m the acsupational worker expoeura would bo only 1.0 fiberi/ee (p. elk He reduces this level by e factor of two to account (or difference* between personal end stone sampling (p. Wk Thu*. Crump s tsnmaies for s 2 fiber/ec standard will be four times lowor than those estimate* c tntde by OS) LA for sverags worker exposure* of 2 fiber/. Such difference* In tisumptions should be k*pt in mind wb*a comparing risk etaasimem* by dlff*r*ot *utk*ta (Crump * esiimai* it 2 t/ee would be aeapand to OSHA * unat at 04 f/eck OSHA hi* prastnted the rtefc * if th* working population were expettd io an average ccncemratien af 1L 04 end 04 fiber*/ ce reflecting OSHA'* belief that t standard at 2 f/ec doe* not preclude worker exposure at that level: in fact ixpowru may even txeaed 2 flban/ce for short periods aid itiU produce an ( boor TWA btlow 2 f/ce Tbo report af the British Advisory Comaittaa aa A*be*to* oontain* on* of tho Ant quantitative nek nstiimenu porfomod (or tsbootoo. Thii we* updated in 1M3 by Achticn and Cardnar (Ex. M>242). Tha report describes ntka for lung canetr. motcthalioma. other aabatto* rsiated cancan and a*b*to*ia and it eantain* a rather thorough doseriptian of the health hagards associated with asbestos exposure. Tha British report's risk estimates for hmg cuter do not differ in e majer way from OSHA's estimate*. Far exempt*. wHh ngtrd to exposure to chrysotil*. the Ashman end Cerdner update *iett that "We concluded that, for example, aa excess mortality from teboatsa-roiated disaas* of I pareant might bo siioeiatod with any point tn a nngo of from S Qb*n/ml to 0 4 fibers/ml end that bearing in tht mind th* vary considerable ancertaintie a figure towards tha lowtr end of the trrey (0.4 (/all aught represent an appropriate compromise* (Ex.(*-141. p. 14). As * eampansan from Tebto U. OSHA's best eslimaM of risk i* that an exposure to 04 liben/cc (ml) would result in 114 ptrctM inents* in death* from lung cancer {or 1143 excel* death* per 100.000k VlTTeckaieil sad CoMomie Feasibility Based on en evaluation of evidence contained in the record. OSHA finds that the provisions required by the ETS an technically end eceaemicalty feasible. OS! LA be* examined the various Industrie* and work operation* Impeded by the standard and their ability to comply with the provisions of the ETS. Bccaese the ETS requires prompt reduction af risk. 0S1 !A pr7 jJ / DUP 0907205 DU 028306 Ttdtul Kaqlttar I Vol. *. Na. 215 / fnd*y. November 4, 1W / Rules nd Reputations tstctsed the industry's eliility to implement tAo required comruit immediately. Th* CTS sbowt considerable flexibility in tehtmiRg th* TO- Ax result. three opt toft ere evsdsbte to lower th atbeeto* fiber concentrations to which worked hre exposed: (1) Engineering controls inch e etometle be| openini device*. epeculued veeitua equipaeat end inoreeeed ventilation: (2) work praeticee. such u wet treatment of the eibeetoa material and toenesed eisen-up of the work place, and (}) uu of approved respirator*. Out to the emergency nature of thi* action which requires immediate rttponaa to redaee worktr tsposure. OSHA aaaumat that resptretor* will be the initial method vied to comply with the CTS. A full diacuaaioa ef the technological and econamie fusibility of the alternative methodi for each iadaatry and tor the various TO* under considered** for revising the permanent etandard will accompany the prepoaat which will be published aepaately. OSK believe* that conetalent with the aaumatts of current eapoturc levels. enfineeHng controls ere cusrentiy to place and work prettiest. in eperouon which, if applied coaadentioualy. would immediately molt In concentrations at least at low at U to many induatrtaa fb.M-inb.M-Ii.M4iidb ** l*>2B). Tor purposes af assessing the tadutoioglesl and acanomic faaaibiliry. kewever. OSHA aaaumad a worst<*t* acanarta to which cash industry segment would have te impleaeat a respirator pregroie in order te achieve immediate reduction to worktr exposure levels below the estimated current conceit tfuriona. fitthirwcrs. fur purpoaea of wont-case uuiyt. OSHA assumed that none of these industries has any respirator program ttnepi for the shipbuilding end construction segments. Obi IA makes this sssumptfon because OSHA esttmetts that moat worked in induetriti other than shipbuilding and conatruopon an sxpoaed tb eight-hour timt-wetghttd averago* Iesa than 9 f/ec. and tht OSHA standard laiusd 1*92 only requires a respirator program when angmaering controls end work practices canaet bring exposures to 2 f/cc. To the xt*at that some (Inn* da have sn existing . reiplretor program, the coat* sre ovfmstimoted. A. Ttehiucai F+HibiUty The following Uhl* preatnta the aitumptiena OSHA made togarding tht rtspiraier program tltmanta required bp each Industry to obtain a TO, ef U f/ee. The types of rtspiretert needed fte etch industry sector wen determined using the respirator select!an table in the CTS with reference it th* estimated euneai exposure condition*. OSHA aiauned that th* least eoetiy approved resplratot would be selected. For example, where indaatrte* have.exposure* last than tan times th* TO OSHA inoetpeiad that diapoeabl* raapiraten wassld be purchased, because ef their lower shortterm costs. When expostm* exceedod ten timet tht TO OSHA tiiumtd that same plant* would efthar uxe afrkne resptratorx. or full facepiece resptrttMO. depending upon the operation. To th* extent that firms cheose a higher-east reaptretoe t* Increase the protection facta* or durability, raepirstor easts may be understated. Furthermore. OSi IA hat not inciuded tn (he east analysis a eonstdcrstion for lost worker productivity due to weertng respiretor*. Co*u atay he undersuted by whatever tmeunt productivity te reduced. Other entjopetad respirator pregrem elements required ta datarmma costs for the ET5 art fisted below. That* elements ire derived from the exittiag provisions found to the Asbestos Standard. 29 CFlt 1110.100] end the standards for artspiretert. CFR iro.134. Ail of th* required rtspiretan end filler* tn readily available end can be purchased through local distributors. Sine* th* program relies mostly on disposable nsptrutort. OSHA considers that then will be ne supply constraints. As the werst-cat* (or high) tttimaia. OSHA aaaume* that approximately 10.000 worker* will wear rtsptrater* bocaas* *f tht CTS who did not previously wear respirator*. OSHA has concluded that th* as* af respirators wtU be tffectivt to providing improved worker protect!ou during tht period af the 01 la addition to taeourtging georreily more widespread use of respiratory protective measures, th* CT! wtU itinniat* a heightaned eadtntending of th* haalth kaxarda from sabtttoa expoton tad will ruth to man tffaettva it* program* and ttnttgia*. Issues involving th* appropriatatati of ntplntoe us* ts a long-tam solution to controlling asbestos axpoeont tru raised in th* section Kb) rulemaking proeaeding (tec Co. *4-04*. H.H1 *4-jar. **-). auaa coat ssiwsmi #r DUP 0907206 J", 7 l 2 DU 028307 5113* Fcdcril Renter / Vol 4A. N'n 21S / Fnd.iy Novcmlmr 4. 1903 / Ruin and d*ai'-*>>r* TAILS 16 Anticipated Respirator Program Elements Required to heet PEL Industry Segment f Primary wanufacturInp A/C npe 6 5neet Friction KattrialS Asbestos Peper fimets Floor Tilt Paints, Coatings and Sealants Textiles wet Process * Ory Process Secondary Fabricators cement meets, Paper Products, Packing and fiasxets Anticipated Type of Respirators Used to Meet me PEL 1 oisposao le/wortuay/iiorxer 2 air-line/plant (for htgn concentration situations;* I disposaola/wrker/day for portions exposed at 0.7S Otntr Program Elements Full aomin. eosts^ Fit Test* Training SOS admin. costs Fit Test Training (Homing for PEL of O.S) oisposable/worker/day for 75% of worears 75S admin, eosts Fit Test Training 1 dlsposable/worker/day 1 disposedle/orfcer/day 1 dlsposable/worker/day 2 alr-llnt/plant for hign concentration situations Full admin, costs Fit Test Training Full eomtn. costs Fit Test Training IS admin, costs Fit Test Training Textiles 1 disposable/uorker/day e Automotive Aftermarket 1 disposable/aorter/day Uefiul ng and Refifing l air-1 ine/plant IS admin, costs Fit Test Training IS admin, costs Fit Test Training t DUP 0907207 jg:t ' DU 028308 fdri KcmUr / Vul. 4*. K,, J1S / Friday. SVn. cmlior 4. vug / Respirator Program Requirements (Cant.) ,,nj Rwulit;ont S1135 Input try $e Anticipated Type of Respirators Usad to Heet tn PEL Other Program Elements Irui Repair gasoline Stations ShipOuildinq/Rtpair impounding Ship Repair Nothing Nothing Nothing ) disposaole/woraer/day for 20X of totsi workforce 20X of aoatn. costs Pit Test Training Construction Instsi itt ion VC Pipe VC Sheet 1 disposaOle/worfcer/day IOX admin. costs fit Test Trsining hoofing Felts Nothing Oeeo 1111on/Kenovatian,, 1 HEPS full ftee for 2SS Of the workforce Repair 4 Hsintsnshce Nothing 2SX sdain. costs Fit Test Training *CSM tssuaes thst certsin jobs such is clesning of vacuum equipment will precuce exposure levels grestsr thin 10 tiaes the PCL. Consequently, OSHA sssuaes 2 aw Une respirstors will oe required per plant except for sasll operations which will require only one sir-line retpirstor per plant. AOir''`native costs represent tne salar- of one full ties professional at $30,000 per snrnn and one full tiae clerk et (15.000 per ennua. OSHA has aojustea aoainutratlve costs to represent expected rsasanaoie tine spent sdaimstering respirator program in tacit industry, in the secondary fahrication and autoaative aftermarket sectors, for example, OSHA anticipates tnat supervisors will spend 15 ainutes a day dittributing and aootto. ing the use of dtsposaoie respirators. These sectors have far leu of a aensgtaeot burden than large firms, and thus, aaainistrative eosts are calculated at 1 percent of the fuli administrative mount. OShA believes that adatnistrative costs have oeen overstated in eost segments in order to present a worst cue seentrio. C05MA assume that every employee Bust be fit tested for-respirator use at a cost of (21 per employes. SoSM hu altowtd i hours for respirator and asbestos training. OSHA considers that this is very liberal, especially in industry segments characterized by saall punts and by the use of disposable respirators. Costs for this eleaent are therefore overstates to present the worst-cue scenario. r DUP 0907208 J 007 - d DU 028309 asiu** rtocrai ncyiaici i yi .n> r rriaay. ,vo>cn'Mct *. i.aj , WMIC> im.-kUi,,iiwi1 0S1 IA aUo tuning the fee<utltty of analytic*! method* tot eteatunng a*bc*tu* air eoncentrattana at tht 0.1 f/ ee limit established by the ETC. OS1 LA's exittir.g ttendurd requires that all measurements af tirbemp concentrations si as best* fibers be made by ih* membrane IRiar method at 400HM x (magnification! (4 fuUimatar objective) with phaaa eaelraat Illumination (U Cfl ttl0.1l(a|). After reviewing tha relevant ividtnc* mid# availabla alaea tha tin proposal, OSHA finds that phaaa contrast microscopy ta a faaaibla and afTacttva method for measuring atrbama iibcaioe Oban to determine camplisnce with the parmianbla exposure lavalt act by tha Emergency Taaporary Standard. Tha meat important iaiiaa raiaad by comment* ta tha tir* notie* ia whathar phaaa contrast microscopy analysts ia capahla of raliably measuring airborne concentrations of 04 Obara/ee and lass. OSHA achnawiadtas that aabaataa airbotna massuramem pracaduraa using phaaa contrast microscopy, as anth say industrial hifiana analytical procadare. Inherently contains several error sources. These srrars have ban statistically avaiuatad by UfcM at al. ** (Ex. ss-42). and. ia 1P7*. by the Air Monitoring Caauniitte af tha Aabaataa Informsheo Association/North America, referred ta herein at AIA (Si. >1 008) hath stini reeedwobia temple aachan| data. Qtatflald alia taaadned thta question (Ex. gS-JWJ. la tha Ltidel at al. sad tha AIA (valuations, tha error, ataaaurad as a coefficient af variation (CV). was bund ta bo raiatad ta tha number of particles caiuitad from tha flltsr. For 100 flban eountad LeideL at iL found a CV af fl.lt whereas tha AIA report found a CV ol 04$1 or errors aisoostad with interiiboratory* intrufilter vanabillty. Baaed span these studies. taken al thsir bca value, it ippaara that tho phaaa esntraat mieroaaopa analysis is capable of reasonably reliable measurements at 04 fibara/ca. As stand in the AIA repart (Ex. SS OQt p. Ahtt 'Tht calculated rasulla indicate tint the TkuAtA e*wM tafwMuy plus Hodw um tw*rw> wamdsuntt Saw u* UeaSM* w dw *w uad nap ms hr a wawwattaadwasaswialNp *--auaislf Aa awU saeplwe snefcst ud pm* naumi at aSaawdauiaW MM Sla confidence lltmta an a measured X hour TWA can be reialively ennaunt with a wide, but uaabld. range down n wtetnirttiona tpprotehmg 04 fibars/ec [less than| IU* 77>e AM report ahowa a higher error than dees tha Ltidal at ai. report. One possible reason for this difference any be that tha AIA report tisaasad tha variability in measurements as they are beia| made today by tht tnay laboratories who are making tha essuramen;: For example. anly IF ol (ha glaborstories participated in the FAT preprara and na counting guidalinaa ware given, whereas, tha Leidei at ai. mpert included inly a aauii manbar of Laboratonas operand by (ahas ManavUle Company, that probably aaad vary similar procedures and conducted similar training. In law 1SSL Chitfleld prepared report antitlad Measurement oI Aabeatos Fibre Caneantratsens in Workplace Aanaphoras'' foe tha Royal CanunusiM as Matters of Hsslth and Safety Arising from tha Use of Asbestos m Ontario (Ex. ChatfiaM analytad Intra-end ir'sr.laberatory variability and arrived tt conclusions somewhat itniiar to thoaa of AIA and LeidtL Chetfield also recommended methods by which tha accuracy tad predates of phase contrast microscopic aaalytical techniques could bo improved Significantly, ho totad la view of die lumber and frequency of measurements required, there is currently no fully developed alternative method (ta phaaa eomiest mtcroacepy) which could be immediately implemented* OSHA none that u<e aathaaitiea attad above believe that it may be posaibt# n reduce phase uanirtw microscopy anon if'unproved sad itaadardiaad precaduros ate tallowed, perhaps by adding requiremanta to da standard, tt daea not appear, however, that improvements af this aatura can bo quickly ends In the iamediau format of ihu ETS. Therefore baaed so tho evidence batata it at the time ef iHsaace of this smargency standard. OSHA believes that it ia generally sot possible to measure asbestos concentrations below 04 f/cc reliably and rrproducibly using phase canmat mtaruscapy undar evtveat laboratory practical. OS! IA finds that tha phis* contrast mxrdtcspy method can bo feasibly used tu me u sura isbcstos air osAcmtraiions dawn w 04 f/cc A XuMtomte frmibuu/ Tha industry easts tweed an th* program slemsms described in T.ibln ll era presented m TableIF, For the ETS. tha casts of asbestos training are included with r*iprefer training. Casts' for warning signs sra not included, lines, tar the purposes af tha ETS. these signs could be hand*made tt vary low eons. OSHA did aot analyse coau assoeiatad with tha alternate benefits aesnene (See Table a) since that scenario was conetracttd to show a lawar range af baaefita but does not represent an aatunaw of currant industry practice Tito coats sra sverttattd to tha tstant that soma firms already have a current respirator program aad to tha taunt that carafsl appliestwo af existing engineering contrail and work practice* would reduce eoncenuedoae to the PEL fa some firms and thereby make reipitstor uso unnecissvy. Furthermore, tha coats assume that dust masks and filurs will hav to bo replaced every $-hoer day. Some af this east (i.t. tha disposable raspinter*. filters and administrative everiwad) can be in fact spraad over the period diving which the CIS ia ia afbet Finally, the soils assigned to tho SMpbuildina/Ripair and CaastarotioR* OtmaUtioa/lUatvaitan segments represent seat which reflect increased compliance with current obligations (g. inenasad leapintae two to moot tho currant standard as a result af the ETS training nquinmeaul and are aot directly annbeuhla to the ETS. Mate. ipgHA aaMpaws Cut the CTI mII spermaay tayleyw who prevseuaiy *m net tnaanpllenet v ~weed Pwneuss*ry ffsmwees in erdev W mom ee eamptieue wnl me ETS. Tht total coat is tetimsttd tt ClAflS.SCa taefl months. Thu rranslstos law an avenge cast par employee of Sn*. Average month costa per worker presented an an ladastty baits in Table IF range barn Uil in the automotive eftornurhat segment to Wffi in the construction segment.These easts are net a large portion of industry shipment* as pmaatod ia Table ta. Moreover, firm to that indistnei will be tbit to puss the costs tarweid bewuse asbnstos subetitutes in most (nduttnes art nut immediately available. For all these reason*. OSHA find* that the ETS t* aesRomicaUy feasible. DUP 0907209 J 0C 7 - 5 DU 028310 ftacrat Ke^:*<cf / vot. . jno, *ii t mojy Tiils 17 UtiMtN Cuts sf Iswpiisp *n$rm t*r ITJ iiM fti sf 0.1 [Mvttrr MsssM Tsui Csttt (SI 1 rttf 1 mm t-m. IrtPIfS Ct/MSlOt frmtri mmUcupim S.44S.H4 4, Hi.2*2 Ul MCIMIP; furidUn li.447,224 7.42i.i22 Ms AtftSNSttVS AfUPSSntt 1,420.1*7 I.U27.M4 at SsiSMUSist/rsAtiP CMtflftlM Tsui 12*.2W *.12*. 740 U,UI,lli 124. S2* 44.SU.402 Ul ill too -?! I m CwIispxs Cmu C*wm Is Mist 1/ iMsltP; M|asrtt {ssustrjr Mfssst CwwMtst SpIS*Py MMfASUffiAf A/C M#S 1 SMSSt fPICtt* MttPUIt AtSSStSS SUSP Ssiau. Csstii IM MsImu CSttSU, lull MS Stttisf* TsidlSt Ucsnsspr fnneitipj i--ll IPMU Ssssr SPSOkMS Statist m Must! TlStt IM tuUsstivt SrtSPMPSSt ISMlISIM MS MftCII# SMIS*I Hi|/U4IP CSHIPMIIW .001 .002 JOOk .001 .oos .001 .014 .on .oil .010 014 .0004 .0001 .0004 MU: Mla sstMS *Pf .ip 1*77 MS IWI. *IM UP JP"JP| KSMfKtMPlSf SM SSSSMtfy fUPltltlPt rtPt turn ,f7* ImM 1st tM MWtltl AftSPSSPSSt mps M*SS *P Jiiis. tiMeutttt^Pitsi)syfiu-tUlMs.tuIMMSf:p-mtsu piUm Up SktsSvMSWiMq/UaM-tr *" MlM fSP (MlPlCtlW * J / t* 1IW MMSr 4 itPMU IM StlS*U*l MS 4S*i| IM )<* DUP 0907210 j n 7 7 .A ( DU 028311 uiiDuMiiauBLaiiiiMiiiui 5TUt Raders! Register / Voi. 41. Mo. IIS / Fridav, S'avcmbrr 4. 1U / Rules and Rctel.mori VIL Cavironmaotai Impact Raquiramaat* of Caecum a Odor ISH. ad the Rafulatory flexibility Act The Nehanal Environmental Policy Act (KEPAI of 1K4 (U-1C14JS1 at icq). <1 implamemod by lha (uJoIiam (40 CFR Pan 1S00| of tho Council M Environmental Quality (CZQ]. requires that federal (fancies asset* iheir rafulatory actions to determino 1/ thora fa a pottaUai be a aifmfiuant Impact on tho quality of the kuman environment and. if necosaary. to prepare an envustonentoi Impact statement ta accordance with thtto requirement! and DOL Nt?A refutations (21 CFR Pan 11 (Subpart B. 11.10 (a) (4||1 OSHA had dotormined that bacauaa of tha amaraaey nature of thia Handsrd. no aavironmaatal Impact ataiamcai will ba parpared for tha CTO. Tha aourt* have held that NTPA doao not require advance praparttun of on anvtraameatal impact statemam for aa OSHA ITS (Dry Color Manafccttinng AnoeaiiM v. US Dtpartmint ofLabor M F4d 9A 107 (3rd Or. 1073)1. OSHA wilt ataaa. down er. tha aevtroamamial a(facta of tha propaaad permanent rtfultima tf atbaataa. Tha result* af this study will ba avaitobte hr rtaiaw and comment pnor to lha hatrmft aa tha prapaaad permanent standard and will ba aa appropetata tana far dlocttaaion at tha public bccrinf. ! lha Jnttrut OSHA walcomaa any eonmenu an any anviranmtntai affects that aiifht acear ta a remit af promulfatioa af a ruia an aahatoa. Punuant to tha authortry af Section OtaRl) af taaeuiive Order 12301 OS! IA hat not prtpared a Rafulatory Impact Analysis af this CTS. Prtpirxtisn af such an analyan was *wi praetieabla fot OSHA to perform m nma to itauc tha CTS la ntpond to tbt nvc danfats laced by asbattoa aipotad worker*. OSItA. howavar. is campitUaf a Preliminary Rvfulutory Impact Analyaia af tha preface! ta raviac tha permanent ttaadard which will be made public at tha time tha prepotsl is pubiishnd. Tha Rtculatory Flexibility Act require* an afocy to prepare a RrfuLttory Flexibility Ajulyaia only faa those rvilaw for which a toiieo af propoaad mleowkinp ia pubinhad. OSHA'a laauance of aa ITS tharatora a at caverad by the RcfalMOty Flndbdliy Act btcoMO the QWHA Act provides that CTS't bo iaoued without tetiird ta notice, pubte cadMcnt and ether reyvirtstata in tho Adminiatrattvr Pmcedura Act Tho paopunul to irvtsr ih.- pnmnaMt * aebastue standard. however ia aab|oct to tho remnrvmenit of (he Retpdatury * Flexibility Act ond OSI IA wiU *\ aluata thr proposal to auertum whethar analysis under the Regulatory Flexibility Act a required. VTft. Summary and Explaaatioo of tho ITS Tha requirement! of (hit tmariaaey lamporary ttandord are aat out in a aaw parafraph. i 1910.1001(h). They arc limited ta additional provisions to tha txittinf ctbaatoi standard which OSHA consider* ataential and (aostbla to protect ampleyaat from tha yrtva dancer retuiiinf from ubastoo aapeaura tarn OSf IA can promuifaic mom caaprehenatve revision* in aecordaneo with lection b| af tho Act. Tha atajor chances in tha itandarf made by tha CTS arc: (1) Tha ittv ptraiieibhr axpoaura lavafc (2} methods tf compliance permitted to aehiava tho new level: and ( a raquimnaat for tha aatablishmant af traiaiaf prafram* within 30 days. Tha foilewinf taction discusses tha majar pravtaiona af tha CTS. tha necaaany far mehidlrtf these ptoviiioas in tha CTS. and leas additional proviatcai* ta ticser terrain requirement* tt tha reduced peraiatibie level of AS f/ee. l. Paratraph (kUU Scope. Aa pan af tha Eft. OSHA is addins a parafraph aa tha scope of tho standard. Tho paracrapb ia intcadad ta nuka doer that tha aaatfancy standard tppiiaa to all workpiaeoa where amployaaa my ba exposed to aabtetoe hi all indtuthca covarad by tba antetat atbaataa standard re. (antral indottry. aaattnictioa and mantime. L Paragraph (kjfi) Pamittibla Iaval afanpatora. Aa pan af tha CTS. OSHA ia addinf parafraph (h)(2) which acta a aaw PC. affective imawdiataiy. af 0-S (/ aa an an i hour timo w ufMtd overate basis. Thia reduced iaval may ba aeUovad by aay (tatiblo combination af anfinoarinf eantrais. freak praetieaa and raapwatory prataatian ia seder to allow amplayara to insblvte alftctiva maasura* to ndueo emeloyea exposurea iaamadiaitly. OSHA shoes A f/ca at tho paraistibl* tapoaura Iaval prfmanly ftcraiina it baitavaa that raduciaf ampfayot exposures to AS t/ee in all induauiaa writ fraotly raduca tha risk of devtlofiftf atbettca ioducod caneen. yriauniy leaf uncar. aMsotholiom and faatraiatcatinol eanoar. Aa act cut in tha diseaseen an frava danfar'* and "bancfltt*. tha number af Uvea OSHA baKevea maybe aavad throufh an bmmadiuti nduetion af axpoaura to 0J f/ee ia auhatanllaL OSHA alra habavaa that lha AS f/ee levd ia spprupriiita far several ether ruasoaa. Xim. because an tfMrfmcy ataaidaadnnaet ba (aanble. and tmplnyan must ba able to comely >nh lha atasjurd in a tiiort emod of time. OSHA has act a Irrel which ia likuiy is be achieved tmmediaialy. atmf equipment and contrul itchniquat Uut < era currently avatlabla. Second. OSHA believes, bated eo the dau fnneratad by OSHA'a contractor. Xatearcb Trianfit fauututa. that acme workplaces, c^woally in tha mxnufaeturfnf Mdor. may ba close to achtcvatf a 04 f/ec lava! throu|h tba more riforoua ate af tnfintcnnf eootrela. work praetieaa sad bouaakatptnf methods which are sow m place. OSHA eneouratta ampioyart to continue (hate effort* 10 implement these rwthoda In order to aaaurt that, for tha lent term, tho moot csmprthtnstt* and affective pepfram af prstactien from atbaataa axpoaura will be provided. Third. OSHA believes that reliability of tha csrrently raqeircd aabtitoa Maturamont methods to manure asbestos axpoaura* last than 04 f/ec should ba apaa for dUcueatoa dunnf a rulatnakint hearing, rather than tapstad throufh on CTS. OSHA hat therefers tot adapted the A3 f/ec Iaval patitioaed by lha anions bat instead ia csntidcnnf addinf provisions to tho asbestos aundard that may improve the reliability of both sampUnf and aaalytia la tha 1(b) rulemaking fa* tha permanent standard and lha* alww lawer lavais to ba raiiably maaauaoA A Paragraph (k)(3l Mathadt af compliant*. Tho CTS adds a naw parafraph (V)(3|. which permits amplayara ta reduce the permituble axpoaura lioUt from the currant 2 t/ee limit ta the AS f/cs limit by aay festal* combination at tntinaaftaf contrala. work practices and rcsptriic'y prataatian. Tho currant requiramant m parafraph* (c)(1) ond (c|(Z| to first utilito cafintcrttf coanis and work praetieaa to reduce axpoaura levels to 24 f/ec returns unaffected by this CTS. flexibility in ehoottaf campluner teateffaa for the parted af #0 CTS hat baan waarp crated ta mast ethar previously tstuod cmaifancy ituad-inii. Tho policy raffacto OSHA'I dotarmitutioa to craft tmeryency ttaadard* that an truly ratponsiv* to tmerptney conditions and which afford immedislaly avoitobla protaetion to (Tactad worfcaea. A Paragraph (kX*/ Srpiey** information and training Tha CTS adds a parafraph to tho aobaato* ttanoani rtqtunna the employer to provide e traininp profrum within S3 day* a( publicsuao af tho enttftney standard far all amployaaa whoa* exposure* r rtasunohly expected to aacted the PFX af 04 f/00. without nfsrd to tha use o( J 0C 7 i7 DUP 0907211 DU 028312 Federal Register / Vul. 41 No. 21J / Fridv, ,November 4. IBM / Rule* tnci Regulation* ij ;jj rstpirutor*. ind to sisurt that all such employe** psrttcipatc m th prvaram and are In/armcd */ipeefled c*ttmnnc* of information. 08 IA cuuiidcre this prevision Id ba *atc*aaery* wIUua the mnnini tf aectiea e) of th* Ad.to reduce die grave iutger faced by aabeatoa exposed cnpfoytes. TV alMcaea of a traintii program requiredt ta th* tibanoi tumdnrd baa bead pointed oul at one of dir rarlaua deficiencies af Lka carrtal tundard. 05HA balieve* (hut pertldpatioa la aa adequate irainiag program la eeeeadal far lh protermee af employee* becauae most proiodlv* prqmaiona aniial Ike ampioyee aa aa active partidpaat. For exampla. may employee* kandling iiUiim depend on effective work practices. Wltkael * tminfng la applying (ke*e work practices. aaipley** protection would b* inadequate. Whan the tmpieyae play* a tar* passive role ia fcia proirction sack as whtre anglaaarlag caatrels are railed an. training lsaJaaeaaenftaL becaeee the employee man know thosourcaeef werkplaeo taboataa eaalamination. aad die health baaarda af aabaaiaa axpaeura. In erdet to asaon his t*va aapoaere situation ud ta kelp racafada whan engineering seotroie are net operating properly. Cartaialy whgre baeaektepwg play* an kopartaat rale la eoavoL kwracflon about heetakaapiag method* far example. frequent vacoualag. ia eereniiaL Furfccpt neat tmpenanly. where aaployea prdactiaa depends eye* reapiratar use. CSHAa experience thaw* that training employees In die eaa. filling and tiiaiUiiaa* af retplfaton ia ctitlcai to die effective**** af respirator protection. Accordingly this raguirvnmt appiiaa where airborne eoneestmtians are rttsatuMy expected to aaaead 04 tf ec a*aa if emplayeea eaa reiptraiaw to reduce breathing sane aancanmtiena and thereby aamjply with the SIX Aa sat farifc In paragraph (kR4) the employer ohms War* die employ** af the health tffeets af ashaatna axpsfi; (ha reiatioaafcip balmran asbestat and tnoting ia pradaslng brag otacan Iha operations aapaalng empwyoce to aabaaiaa Oban ipd aacaaaary protective siepa ip mbriafa* axpesosc the purpose, proper uao. fitting tnatractians and amiiiidaiH afrospintor*. and ike eootoMoafnltheprseistuMaf the Aabriaa Standard it iruuoot. 1 Awapnap* amtMmpimary prvtirfw* thong the ITS. Tkc ETS add* new paragraph (kKSI which indudes a labia which boa nwpiiMae selection 10 th* 04 f/cc PR. Under the ICH iha csnceairatiea tut-vfTi far varhwa kiada af toapiroiota an> multiples af iha reduced TO, of U tics. rather than multipica of the previous 2 U ec permissible limit. For exemplar tpproved air purifying respirators may be sled eniy whan* eebealoa eontenirut ton* era net expected to exeeed 2 f/ec (10 a the PELL Oefcrt the m bccaaaa (ha PEL was 2 l/cc. such respirators cauitl be u*td where ibeelat concentration* wauid aei have exceeded 30 l/u (10 a the FL of 2 f/ecL Similarly, pewared air purifying raapirtiora may be used where esbascoi eeaeamratlooe da apt exceed 100 time* the PEL which al the aaw level af 04 f/ oe ta JO f/ec Previously. employ*** coald have aead such respirator* at concantralions up la ]00 r/ec If is likely that iha mala impact tf iha reduced PEL an respirator choio* well bo la opera(ita* end Industries where exposure levels arc between I f/ec aad 20 f/ec Formerly, employee* expand la this range could uso half-auk air purifying respirator*: now they meat be protected by a powered air purifying respirator or a full faoapiec* reaptrater. at they may <e a supplied air laophator. ,, 1 AmpgncpA fijflj. Warning lipm Jumt$ tA* T5. TTia TS raqidm that tatW* eigne warning of the health kacarde af aabeatoa be diaplaytd at locations wkert tlrboroe coaceatntisna af attemtoa fiber* axcaad the teduaad tapaain limit af0J f/oc. No specific legsssd is rogairod ligae far aewly posiad during iha ET1OSHA wishaa to make ae praeticabla aa poeiibla the rapid posting of signa. eipocully in warkpiaco* wkert there baa bean piuvlau* ncA'Cooiptianca and in areas where aebooiea cencentretieA* ware forsaarty below the 10 f/ec PEL % XL PubCo Pettioipaitao latcreatod peruana art Invited to submit mtuned*ta. view* aad arfomrtts with raapact to the revisions to tho aabeatoa standard mada by Urn ETS. Thaaa comateats moat ha peatmarked on ar baton January L ISO* aad tent ta iha Oockat Officer. Docket No, IL030C Occupational Safety k Health Administration. UX Ocpaninsnt of Labor. 200 Constitution Avtnsc. NW,, Room S-C712. Washington. O.C 20219. Thg data, vtgws tad arguments that art submitted will be available far public tnipemioa and copying at the above addraaa. Ail timely written saboMsicoi witt be made a part of iha record of iha proceeding. Uat af fbbjecis In It CPE Pari 1*U Oeet^oiional safety and health. Asbustex. ilvaith. Fmergency tamparsry sUMfardk Caocnr. Authority snd Signaiura Thi* document w.t prrpurcii untli-r (ha direction af Tkumc C. Auchnv. Aistaum Secrttury af Labor for OccopMlonal Suf*ty snd I Iralih. UX Department af Labor. 200 Conxiftutian Avenue. NW. Wushinspen. DC sniio. Fanucot (o S*cu*n ifbL Neb g(el end ffgj ef fte Act 9 OE 1*10.1001 is smended by adding a aaw paragraph (Ll u sat forth below. ISnm mu gck Kef aad N*J Pub L tl-ttc Miui tw. tMb use. tcmmuxctai. u* ht ter. Aik. L fiS4.0 Ir.t m no uj c k a ent r.n 1*11. *r*rur> Labar* Order Na. -(<* f* urpeu tigaed *i WtahtagtaA 0.& ik>* 0r4 ibt ol Hniabr Itt Tim O. AudlWr. limmttM fUQ rfUbur. PANT IS10-fAMSNOCOI Saettaa ipiaiooi of Pin ii0 of nd* 20 af th* Coda of Federal Regulation* a hereby amended by adding a aaw paragraph (k) reading aa fallows: | ISM.>001 4*010*01. M CworMwcy fmporvy nation! effeeff** fmimitr 4.2MS-<t| Scope. TM* aaatfasey temponry ttcndtrd i* Imuad pumant ta section Sfc] af ih* Am and applies ta all workplace* wh*n empteyaaamaybaaxpoaadtoMbanaa in all iadmtria* eovarad by. the An. including, icnerai industry, constracnat ad ataritiius. Cxtapt to the xtant modlflsd by thi* tmargancy tampom'y tandard all provisions af 11P101001 mtnain in effaat. (21 Pumissti/r tfexpeturc Th* Pkaur dma-watghied average airbanta saasanirsuoa ef stbaitos fiber* to which any tmpluyaa may be aipaatd shall oat axcaad ene>)wtf (Ul Ohm. iongar than I mterametara. per cubic eeaumetcr of air. aa ditarminrd by the method preacribed in parugr.ph (e)af thtsicatian. (21 AfciAmdb f complionco tviM thr eawiyrncy umporary itondcrO. Nutwithstandiag say other raouireT.en af this section, complianca wtih the reduced expotar* limit of 04 f/ec ba achieved by any feasible eambtflaiioa af engineering eontroii. work practices, snd pamaal preiuetiv agaipment and device*. (4) Ewpdeyea mftmmion and Uviaittt.--(i) A* toon is posuble, U.i oat Inter than thirty (X) days fmm iftt effectivf data af this emergency temporary siundard. th* empiuyrr ik.i lasiitul* a imiAina erecram fur *11 employee* *spovd to airbornu .oaoecairuituas of asbestos m ttr.m i DUP 09072Z2 j : 3 ? / 2 DU 028313 SlKfr Federal Regtier / Vol. 4*. No. 215 / Fridny. November 4. 1903 / Rules and Regulation! M f/ce. without rtfard to the eee of eptreior* and shall assure their perttdpetioa m the propria durln| (he effective period ef this ereetpeney temporery standard. ' (it) The etnployer shell asure (hot tech such employee ie tnienoed of the followtar (A) The health effects eModeled with eebeetoe exposure: (B1 The relatiotiahlp between eebeetoe end ifflokinf hi produdn lent uncar. (C) The eatare of operations which could reeelt in espoeure to eebeetoe end necessary protective etepe to etinirelxe exposure aciudinp. ee applicable. en|ineerut| concrete, work practices, resptniarx. hoeeekeepinp end protective dothin* (O) The purpose, proper use. flttln* lastractione end limitations at ree^inton penaitted by the standard: (f) A review of ail the prevtaiaae oontaUed ia ltlO-JOtn. (S) Ratpintartprauetiaa burins the ITS Notwtthetendinf say ether rehuireaeat ef thie eectioa where reepiretere ere eeed le achieve the perinietible espoeure Itaut at 04 f/cc they than be selected eocardino te Tablet. __ __ (!) Waning tyiu during tha STS. In oddities te the reeeireeiente ef pemereph (p|(:) of thit taetion. ie(bie tens wartime of the health huurdi at ubettes shull be provided and diepisyed et each location where airborne ceaceniretienj ef eibcstet fibers etoy stated 04 f/ee. Tapia i (etpiretery Protect tea Per Atraeme Ceccentrctieae at Aeeetut . Airpeme Ceaeantrattee 4 Ateettet tTVA) Set ta tieett at I f/cc no i nil let ie excess at to f/cc ooo i nu treater taca U f/cc levtale er tt*e'* ete etr purtfytcf respirator Pelt facepiece etr purtf/tsp resptretcr, w a peeered air purtf/iep res pirator A type *C* caattaneut fine er pressure Ccoana. tapeltec etr resptritar. 1 Aespiritcrt tpectfiec far stpa eeacentrettaac oey ee vtec et tear cenccxtret tens ef ueestes. (Sees. MH MO. MO end OfI Pub. L. rt-OCA ee (let ucs. tSMA UN. te 9 U4C Ul ear: Pec ter. Pub. Ln-M.ciStat.se (as U4C SPh S OM Pert tea leertta/y ef tabor's Order Ne. *4 (as PI isnsil pue wiiwun i maw d r i a* l** DUP 0907213 J 03:9 DU 028314 m.eS,a^ /^W a-iUutt^at Pt'A, ^ / .X -.-^*1 vL^o'^--6wl'''-o'-^ (AZa iitJ Environmental Note Novenbe^ 9. 19 83 ^--7 '' i' All Departments AIA Lawsuit Challenging CSHA Emergency Temporary Standard on Asbestos The Asbestos Information Association (AIA) has filed a lawsuit in the Fifth Circuit Court of Appeals challenging OSKA's issuance of an emergency temporary standard (ETS) on asbestos. As reported last week, the ETS lowers the permis sible exposure limit (PEL) from 2 fibers/ee to 0.5 fibers/cc. The ETS was published in the Friday, November 4 Federal Register. The AIA is composed of approximately fifty companies which manufacture, use, or mine asbestos. The Association has not determined whether it will seek a stay of the standard, but will make this decision by Tuesday, November 15. Ed Warren of Xirkland and Ellis is representing AIA. *78 DUP 0907214 Jw 3 DU 028315 ail-rbiii ii.linttlrnrtiiii iitiiim ,i,.iMiii nMmMt.au 11 Friday November 4, 1983 Part VII Department of Labor Occupational Safety and Health Admlniatration Occupational Exposure to Asbestos; Emergency Temporary Standard DUP 0907215 DU 028316 5108. Federal / Vol. 48, No. Zi} / Friday. November 4. tana / kuics unu OCfAMTMIMT or LAiOA Occupational Safety ana Health Admiruatratlon CFR Fan ttso (Socket w*. h-03301 | f Occupational Exposure to Aabectot aoimct: Occupatioa Safety and Health Administreuon (OSKA). Leber. aenotc Emergency tetnporafy Handard. SVMmaokOSHA la Issuing an ____ emergency temporary itandard (ETS) to reduce the parmiesiltle exposure limit (PEL) for asbestos from Z fiber* (!on|er than S micrometers) per cubic centimeter (Z f/ee) at an sight-hour time* weighted ev*r*t*. to OS f/ee. During the penod of the emerstney standard, employers may use all practicable control methods, sueh as engineering controls, wars praedees and personal protective equipment to meat the new limit of 04 fibers per cubic centimeter (04 f/oeL Training programa are eiao required to be instituted witiiie SO day*. The basis for this ETS to OSHA's determination that continued employee exposure to ubestoa under current conditions that essaed 04 f/ee preaaets a grave danger ef davtloptag asboatoa* ladeced caster end aabesteeit to exposed employs**. and that an emergeney itandard is nacsssary to protect them. The ETS firm alas t* a proposal to revise ths currant asbestos standard pursuant to iieaoc Kb) tad *(e| of the Act this notice also requests comments on the eppreprietsntss of including the provision* of iha ETS * permanent revisions to *>< asbestos standard, la addition. OSKA will soon publish a separata r.stice of proposed rulemaking that father explains the issues under consideration for the permanent standard and which raises seat* additional issues regarding the appiieetica of certain promstone ef the eebestoo standard to the construction industry. That node* will invite public comments and will schedule e rulemaking hearing pertaant ta Section Kb) of the Act cencendnt the proposed permanent revision to thp asbestos standard. oamc: The effective date for this nti* Novextber 4.1M1 ComxMata and evidence conraiHag the proposed revietoiM to the pmuaeat itandard made by the ETS mat be received on or before January 3. tape. As acted. OSHA will pubtisli e notice ef propoeed rulemaking shortly that will sat due dates for submissions to the aebeetoo deckel for the issue* relied (tiwtin. aoeastMl: Wniten comments should be submitted to the Oockct Officer. asbesttsit) among currently excuses workers which ere attributable to Docket No. H-033C. Room S-IZ1Z. U5. eommutd sxpotum ander prtsent Deportment of Ubor. Third Street end workint conditions. OSHA (stunned Constitution Avenue. N.W. Washington. '-he number of cancer dtaths avoided D.c. zona through lowering of the exposure to 04 ; roe suarMta teowa-iON eoMtaer. f/cc. based on I months, i.ytar. 20-ytar. Jama* F. Fester. Director. OfTte* of and 4S-yar period* of oxpoturot at Information end Consumer Affiirt. current levels.` The predicted cancer OSHA. U4. Department of Labor. Room deaths (voided that result from these N-34JT, poo Constitution Avenue. NW. periods of exposve ore respectively Z10. Washington. DC Z0Z1S. Telephone (202) 428. S72I sod FttA A more detailed m-otii. diacusstofl of these estuneits is found in tuoomaMTaav atfonwanoK TiMeafCeaMM tha sections. Quantitative Risk Analysis (Section VL Crave Danger (Section ill AL end Need for sa ETS (Section If] B). Llmiedumea 0. LegsJ Asthertty end leckgreead SL OSHA Rabeasts tor tea ETS A. Cm** Oanger I. Nsed far aa CIS Suffinui gatxmarwDOr Risks of this magnitude at permitted end (duel exposure levels defined a situation which demanded immediate (natatory action. Evaluation of ths relevant scientific data, policy costsiderations and exposure patterns of fV. Occuoedonel Health Data V. Quaauieu** Risk Aaalyw* VL Toduucel aaa Ecsneaie Feasibility A Technical Feeesbility t. Eaeneeue Feessfedity VS. tnvxvnaeatai !**, Regeiatery FUeiOJity. ead Reyatotery Analysis m Suamiary ead CaatSMboa ef the ETS workers has convinced OSHA that continued exposure at the currant PEL ted under actual workplace conditions ccastitutat a `grave danger" to employee*, and that ta ETS is neadad to protect them. The ETS requires that smpicyees may DC PsMK taruepeuan. Authortty ead Signets**. tad Pan HU (/jneadedl net bo exposed to eoncomritisai of taboetao exceeding OJ f/ee an in 8-hour L btnducdca This to aaMMfgexdy ter*penny etaadard (ETS) toeued pursuant ta sootiest Ke) of the Occupational Safety time-weighed events basis, and permits ths employer to choose among ngiaeortng eemreto. work practices sad respirators to radaca expoeurts to ths nose PEL- Howsrar. the rtquirtmtat in ead Health Act ef ire (she Act) (M I IfiaiOOlfc) to stiltoa fessibl# Itet IMA Zf UJ.C US), the engmsaring controls and work practices Coftsmxriios Safety Act (?ub. L P1-S4: to reduet exposure tovato to 2 f/ee SO U4.C. 333L the Loitgshesomea't end - rexioin* la eifeet ander this tsmperary Harbor Workers Cempaasauon Act (U standard. Tha ETS also requires US.C. MIL the Secretary of Labor's employers to inatituto a training pragrsm 3tdor No. 8-83 (48 Fit. 3*7381. and * CFR Part mi. Thii mergency standard eanatats of rovitiees ta the exiactng standard severing oecupetiona) within thirty days of the effective data of this emergency standard. The training profam will include instruction on rtsputtor fitting snd use. handling of exposure to asbaatos. Zt CFR TtlO.lOOT. la order to protect employees from o ' grove danger from continued exposure to arbestos at current exposure levels. OSHA has determined that wotkara aibastot. medical information, tha rolatienship between smoking snd lung cancer, and a review of tho asboetoe standard. The ETS applies to all industries eevotad by the Act. including exported to asbestos under exposure "ganerai industry ", construction and conditions existing sader the current standard face a grave daagar of antima Industrie* developing tneutabto eanear and abettosi* Further. OSKA has found that aa imetadiota reduction ut exposure level) to O.S ffee or below is nocsesary to protect such employee* frsm this grave danger. Therefore OSHA to toautng this ETS to eempol reduced exposures to respond to this tmargency Situation. OSHA's detertniaatloa that a pave danger currently exists is predicated upon quantitative risk estimates in this record which point to s targe number of ueeus deaths (ram camcar (and "* * QU4A a ma t( WWW. *mi Swum Vel ( to Aar tmtm w tttttun w win CTS tat --* mt OSHA wmlilOw Ow i PI'I lii| tmmm mo tv rrs mmo rvw 4 OSHA bun new* ray * mi stntt. Hsaewt. rtt A(tiy kum a semantic ic veteuku* bcMfas 4*ww* tm > CTS con* Vfcmwc mu (few la 4M ct ycen < tvsewi* * w rrz. WSI t/w rwkl fWC r ' iTS AUMutn Wc Rg >env* witttr 4 weal** Sccuea kcl M*am Wet wtnrtwt n i scw.umii aaiulcrC Ut* St --eliHC vnCwi 4 (Marts, w umi rtcnr WW * Skew WVSCIMk fw MWlkl imtttk>f la OStlA't natnrtm Ikk wOtciifi. csw*.fia wva (a* akWMry (uceifw ut wwsnns nkswsSim tor inaucil tisnakfV mt* t anMOMRitoMMHtlM 1r Jo rw -. - wc, DUP 0907215 DU 028317 As provided in 29 CVR 1M3.2X the g* Suite with their own CSliA-sppmvcd occupational ssfaly end health plant art sxpaetrd la edopt a eamparabla tundard within 30 day* of this publication data. Theta tlalai arm AJuke. Arizona. Cfifemia. Connecticut (for Stst* and iocal Jovamsumt ' tmployte* only). Hawaii Indiana. 19we. Kentucky. Maryland. Michigan. Minnesota. Nevada. New Monies. North Carolina. Oregon. ihiena Rico. South Carolina. Tenneisee. Utah. Varment Virginia. Vipjin lalandt. Washington, and Wyoming. Alas, in reaponie to the tmargency condition* faced by anpoiad worker*. OSHA i* supping up its enforcement activities ta urgcttng workplace* wham aabattst i* handled. The temporary provision* that art b#in| idded to the *xi*tui| asbostot standard prosertba* ths rnsjor esapenaatj of an occupational aafety and health atandard. In itnerai. aioat of the current roauiromanu remain unaffected by the smsrgeney temporary standard. However. eompliane* with . soma raguiramams will be triggered by the now anpsstir* limit of 0J f/ee ... tnatoad of the former PEL of I f/ee. For example, requirements tueh at changa * Tboms f*m*tn unaffected by the ETS and the trigger laval for changa rootna * rttnalni die fnrmar PEL of t f/cc . (I l*10.10Cl(d)(4)). Kowwar. the ETS requires that wham csncantratioea may txcaad ths nw PEL the amployar muat paat signs indicating rack location* (| WU.M0t(k|(9n. OSHA baaed ita dastioca concerning pproprtata provisions for tho ETS on its determination* of the kind and degroa of prottctive action naadad to protect again it a grave danger and the feasibility af instituting thasa provision* during tha pined of the ETS. Uadsr stctton Stb) of the Act OSHA will shanty schedule an informal ruiamtking hearing an tht proponed permanent ehaaget to the atandard. OSHA will alia propose other rovislona ta the asbaitos standard that wilt bo titplbiMd m the leparato nodes of ptopoaed rulamakiat. ApptUados of certain previaiase af tho astxialaa standard ta the construction industry will b* raised at thatlimo. OSHA aaticipaua that thta nmiea wtU b* pablished ibordy. OStlA is sow accepting wrtttan comments as those isaues raised is tho ETS which art relevant te imrUiag the permaaest ruin. The Seerotary muat promuicate a aaetmn S(1i) standard nn Later than tix months after putdicanoa of the emrrgrncy tumiiani. !L Legal Authority and Sackgrouad xpoed workers 'h*ir iiv. OS11A A. Uva! Authority Section 0(c) of the Act provides [or Immcdlaicly ifTreiive tmergeney temporary standard* in cerium etreumstsnee*. Ths Secreitry has th* uihonty to ua tueh a standard, without rulenskmg. 'if he dcurrmnci (A) that smploytat are tsposed lo grave danger from exposure to subtleness or sgtnis daisrmined to bo toxic or physically harmful or from naw hnsards. and (I) that such tatrgtaey tundard is aeefj~y to protee: employees from such danger.' 29 U S C SM(e)(U That, the danger must be `'from' worker exposurt and U must be "grave.'' not merely significant and tha regulation mast bo "aectssary" to address 'such danger.* not merely reasonably neetisary or appropriate to provide safe tripleyment. In addition. as m taction cfb) parmanem atandard*. OSHA may impos* rtquiriments in tha tmsnancy suadard only ta th* axtent that they are Tsasibla" within tha meaning af taction KbKSl ofthsAet. th* Fifth Clreuithas amphatUsd tha (mporunca of th* seventy af haalth affacu m OSHA's oonstderatios of whether an m is appropriat*. shams the (cm.:.; concarn expressed by tha petition and lutiers from unions rtpresenung ihousnnds af employ scs who aro directly faced with the thre.n of asbntovieluted disease from continued exposur*. And OSHA concludes that failure to issue this ETS may can a number of exposed workers their lives. In August 1K3. OSHA completed a comprohsnstva risk auasiment based on aumernus human snidiis which eiitmaied tha numbar of axesss dcsih* from ih* throe ma|or ssbaitss-raisiad center*. (.*. lung tanear. mtsoihuliume snd gistTointestinai unear. st Ih* current permissible exposure lvi of 2 f/ee snd st vurious reduced exposurt levtls. OSHA plsesd this document. Quenti'attv* Risk Assessment for Asbestos-Related Cancers', la th* Asbestos docket in August 1M3 (Ex. W- >49!. OSHA subsaouentiy revised this document (See Ex. *4-4021. L HIttoty af tha Aabattea Standard. OSHA hat rogulttad asbestos tuica 1971. A 22 f/cc limit fa; ssbastot was included in th* initial pramulgailea of OSHA standards pursuant ta taction 9(a) of th* Act on May 29.1*71 (>* FR 10409). In raspoasa te a petition by the Industrial Union Department of tha * * ike danger af iaeorabl*. parmanam. ar fatal canttemnctt to wwiirt. ts ippauf ta aaatly auraIda and fleabag affects an thee health. Paceout impertanl In tha aoaaidamtiaa af tha aacaaeSy far amomsnty taeararn ta meat a grove dangrr." Htnm AvocA Oraworn AsaemtuOs /ns v. Umtd irtM* Orpenewe/af Lsher.-aaM Fdd. 1U AFL-QO. OSHA issued an ETS on ubestes an December 7. itrt. which attabiishad a PEL af I f/ee ea a timswaighted avaraga bast* and paak axposura* af 10 f/ee. Tha currant tundard. premulgiud in [urns 1*72. first tstablishad an 9-hour (Cash. .. tins* weighted avaraga PEL of S f/ec and OSHA lira has intarpntad relevant judicial deeiaiena to roqoire that ita valuation of tht gravity of th* danger and the oaeasaity for emergency action moat ha mad* in tha eontext af actual workplace eo.idilions J. flac`ground' a calling listit of 10 f/cc. Tha limits wars intandad pnmarlly ta protect emplcyess agiintt asbcttoiis. and it was hoped that they would provide torn* incidental degree of protection against cancer. Effective I.., 197*. the TWA limit was reduced by the tundard ts 2 tlcc. This Draft hat remained in affaet tinea that L fvonra Laadint to tha STS. In funs time. Tha standard site includes Itad. OSHA reserved a petition for an provisions cowing methods of ETS from tha Intaniitlanat Association camplianea. monitoring, medical af Maehimsu and Aerospace Worker* surveillance and hausakacping. (Exs *4-2 vs). Subaanuantly Itutft Court review of this standard upheld supporting this petition were received all mejer previsions. but remanded iwn from 1# o*her unions (Ex. g42*4 te 94- , issues for OS1 lA't reconsider*non. /JO 214.14-417 to *4-391). Tha patition v. Hodgson. 499 F. 2d 497ICAOC19741. requested aa ITS ta roduea tha PEL to Thasa isauac wtrv whether the July 1979 0.1 f/cc. ta modify some amsung work dau for the 2 f/cc standard should be practice requirements. and to roRuiro sccalaraiad for iomv industries and the otkar pmiaaiva *revisions rogardtaa* of adequacy of tht > year raiantton period exposure IcvsL Tha main reasons sst for exposur* monitoring rteords. forth in the petition and supporting SubasRoantly. OSHA inerasttd this letters ar thst continued exposure retentie* period to 2u years (41 FR under current workplace condition* 11804) snd tht acceleration lasue constitutes s grave danger and that became snout. delaying remcdf.il uetion until a After reviewing the then iivinlnhli- permunent standard it promulgatad scientific data, in October 197S OS! !,\ would coat larga number* uf currently* publiahnd a nonet el proposed 0596 DUP 0907217 DU 028318 fioaa Fcgeral K'U'Sicr Vqi. eg. No ;-j , Fnduv. .Novemi'er < mgy , RaiM ,na *e,Jlu, rulemaking io r*nt the esacstoe standard because OSHA believed iht "sufficiem medie.l snd scientific ' vitienct had been accumulated la warrant iht dea.gnatten of asbesies n a human carcinogen'' and that advances In monitoring and protfctive lechnulogy madt reexamination orJt* standard "de;rabi." Thia proposal would have rtduttd the tini'Woi|hitd evartgt 10 OJ f/ee and imposed a eettmg limit of 1 f/ee for IS mrnutrt (40 FK 47852). Tha bans for in a 11?J pronoial'i raduead permissible la*el of lU f/cc waa OSHA'a then currant policy for earmnojen* that no aafa threahold laval waa damonatrabla and. tbarafora. tha Act required OSHA to aat Uta PEL aa low as tachnols^ieaiiy and sebnomieally faaaibta. Thia policy waa rajaetsd by tha Suprama Court in tha bentana decision (IVO va. Aft. 44 VS. 101 (isaon- OSHA limited tha propeaad ravisiona in tha 1171 nodes to ail industries aaerpt construction. No hairing was achedulcd on tha 197S proposal Aito. aithou|h OSHA aanouncad its tattnties to develop a separata proposed revision applicable to the eooitrueBon Industry, no such proposal has ban published to data. OSHA is bating its present decision to luut an ETS. and to propose revisions to tha permanent standard waring alt employ***! on infotmtuon ond tntiytoa which pootdata tha ltr$ propetaL Therefore. thia ETS marks a saw regulatory initiative, related to. but not part of the 1971 proceeding. On Moy 24. IMS. OSHA conaultad tha Construction Advisory Committee for Occupational Sofoty ond Htalth (CACOSK) concamui| applieabtW>; of a now aibastoa standard for t*ia construction tadaairy. CACOS.. ..idorstd OSHA's positum that changes m the PEL mad* for itniral industry should also apply to tho conitructtoa industry. OSKA is also including tha esmmonts and data reettvad ta retpensa to tho tarj nouea in tha reeard of thia proctodtnp. with tha understanding that soout cammomars may hava changed their psatnana based on inttrvamng saentifie C*v*lp*ms and policy shiita. In tha decision ta itsoa aa CTS. (ho Ataney his rtviawait this repuiatory hiatery of asbaitoa. However, tha Atrney baser tha dactama to taaua an STS on tha actual emeryancy aonditiana which now csnfnmt txpoaed worker*, on eptdeimolufJc ttudias that provide date to asaka aamarteal aatlraaiet of risks aod on imetpratationa of these aiudia* using goxntttatsvt risk enaiyita. 2. Tht Aufaniakinq iu Uevma tht farmuartv Standard. T!.c C|b) rulemaking initiutad by this prnjumiil i* uitcntiini iu be limitcu to the revisions nvmj* by the CTS and the sdditmnal proposed amendments ruiieii in iho notice of proposed rulemaking to be published soon. The ir.aior tuBieetl of the S(h! rulnmaxing will be: raauem* tha parmiisibla exposure limiL revising tha dcfimtiunr of asocstss and asbestos fibers, reassessing tha methods of eomplionca to achieve such limits, revising the provisions regarding respirator selection. ranting tht campling and analytical method to Improve reliability, and adding a training renutrement. OSHA will also rata* issues regarding tha appiicanon of tht permanent standard la (ha construction industry. As previously ititta. CSKA will soon publish a separata nonce of propeaad nsiamaking to further explain these Issues. IU. OSHA's lUdoaxle for the ETS OSHA has datermmad that pravatling conditions involving worker exposure la airborne asbestos dust |ueufy the promulgation of aa etnergeaey temporary standard. OSHA eatlmotee that approximately J7J.000 workers ara exposed to aibaatoi at various teveli (Table U. ranging from a high value of 20 f/ec to below OJ f/ce. OSHA hat eitimattd that under currant axpoaura conditions aibastsi-avpgsed workers face an txtraordinarily high risk of contracting aabattaa-ralatad cancer whathtr the nak ta computed aver a waridag lifatima of txposxra or far txpeatsra ptnods as abort at months. The average excess cancer riakt for all workara exposed above OS f/cc uatng available axpoaura data and relying an . tha nsk assessment are estimated as approximately 199 txeatt cancer deaths par 1000 worker* for 4S yean of axpoaura. 1M d*at. par 1300 workers for 20 years. 10 par 1000 workers for 1 year, and I per 1000 worker* tor 9 month* of exposure. OSHA batwvea that ntki of that* magnitude*, taking into account ail relevant considers nans such at total numbei* of.wnrken at nsk and qoaiity of supporting uata. constitute an emergency situation which requires immediate response by the agency. Tie Act states that whan certain statutory entarut art met. OSHA is authorised ta raopend to an ttnargtney situation by issuing an ETS. Tha two, pronged statutory tost fur an ETS is that (1) amplayaet mutt ha exposed to a grave danger from axpoaura to luliataaeot or agents determined to be toxic or pnysictall) harmful, and that I2| ah emergency standard it atceaasry to protect ainployaae from such denser*. After evaluating *11 the evidence aviuUlile to the eganey concensus the seventy end magnitude of the ruk of aebcstofTtletcd diecast io the current ttb*|io-axpot*d working pnpuUuon. comparing those nsxs to other oeeupulional niks. soplying ralev.int policy considerations, and reviewm* til ralavant ludiclai decisions far puidunce. tha agency he* Oatarmirwc that bntn prongs of tho statutory last art mat and that an ETS should b* promuigttod. For purpoaoo of cltnty. the ducussien is divided lot* two parte. *Crav* Danger" and "Tli4 Naod for aa ETS." OSHA belitvaa. hewavsr. that tha faetora which indicate that a subttanct eanstttutas a grave dangar are rallied to and ovarlap those which dttarmint that an CTS i* necessary- A. Crtra Cougar OSHA bat determined that tht nsk to workers from axpetum to asbestos at conditions that exist A tht workpiece pot* a grave dangar of death from cancer and of aavart disability from die lung disease, stbastoiis. In making a `grave danger" determination, tht avanty of lb* disease praduced by axpoaura is tbo roguiaiad aubstanco and the magnitude of tha predicted risks of disease must be considered. In addition, tha Suprama Court has suggested that a determination of `grave danger* Indicatta a situation where tbo riik is more than `significant'' (/VO v. Aft. *upra .). OSHA baa applied that analytic eppraaeh tndaraad by tha Suprama Court for `significant risk" detxrminatlanx ta avaluatlng the gravity of tho dangar ftcad by asbestos-exposed workers. Tha Suprama Court gava tom* gonaral gaidanct aa t* tha proeatt to bt toilowod. It roeegnisad that while tha Aftncy mutt jupp^f* its finding that a etrurn tavti of risk exists with substantial avidanet it alao recognised that ita determination that a particular laval ef risk is `significant* will bt baaed largely on policy coneidtrattuns (7UDv.AiV.449UJ.iai.tse. ft. S3). OSHA believes, therefore, that its determinetiaas regardim; tha magnitude of tha risk faead by tmpleytea snauid. to the talent possible, rely on auantiutiv* axpeeaatons of that nsk. utilising tha boat available data. Tha Court stated that tha significant nsk dttamsinabon required by tha OSH Acs t* "aot a mathtmatical straittacket." and "OSHA ta aai requited to euppori Its finding that a significant nsk etuis with anything approaching scientific certainty. '"A reviewing court (ix| lo give OSi IA come loewsy where its findings muat be marie on the frontirn of aetmtific knowledge [and th.it) the Agency it (re* ta uaa constrviiiivc assumptions io interpreung ilia d.ita J 0C f;7 DUP 0907218 DU 028319 Ft<jral Unginer / y0i, <8< No r3 / Ffid^y Sovchtbcr 4, 1383 / Rule* and Ragul.ittone 510159 with reipret to carcinogen*. hiking error on tha tide of overproicetion rather than uadarproteebue* (4M L'S *t US. &M|. In tht cut ot ubtttot. tha data availabla are of unutul breadth and high quality. Howv*| because nak (iiinmtm itself iATqivai many uncertainties. OSJiA feed* certain attuaption* m ita analysis and evaluation ot thee* data. In aiMtaint tilt nak for asbestos-exposed workan. OSHA kat attamptad to nee raaliitie aatampdona. although tht court atatad that tht A|ney wai froo to uaa 'eonservstive titurapueaa" in Interpreting data. OSHA. ia many carat, hat ladieatad "hare different aiaumpuons may product different raauita. ia tdditiea OSHA cautions that baeauaa tht nak fiaurta iinaily derived art tha products at a pracaat which, at tht Supramt Court acknowledged. ia "on tha frontier* of sdtnc*.' they ahould ba viawad aa approximations of tht dogma of hak faced ay asbtttes-txaoetd workara tad aot at proas* fixed pradietioat of tha lumbar of workara who wtli actually develop dictate. - OSHA baa evaluated the ktnda of dangers preaantad by atbettoa exposure. the quantification of thoee dangers under preaant ubailee ' cxpoiuaa-conditiosa. tht pualily ef the ' data an which tick estimate* are bated, a companion ef aabeetoe naka to ether occupational risks. aad relaviat policy and litfal eonaidaretioaa bt condudinp that workore an exposed to a prove danper from aibeatoa. t. Notun oftht Ditoatot. Aa atatad above, the atture ef the dataat aiaodatad with axpotara to a toxic aubatanca la ona u Jts stoat important laments OSHA rvaluatea in determining whathtr a prove danper exiett. This faeter was discussed in Florida Pooch Gronon AtttciiMaa. Inc. v Unittd Slam Depanmoat ofither. supra. Tha eaun. ia overruling OSHA'a orpinophoaphate peaudde CTS. observed: Wo rtfaci any nieeaaltao that dtatha Mat cmr before twrUh aad uftiy itaadaidl may ha adopted. S'cvtrUwieta. tht darptr of uicutobhr anwttot*. orfPmi ctnuautoott to worhert. to tpptotd to ttmhr aurah/e ltd flootmt ritoeu aa dear haqkk. tirnaii these disaases err luna eanerr. canetr of Irveie which worker* eurrtntly fact. tha mtasthcliui Iirurtp of tha pirura and Meat af tha results of thtit eaieuiutiont peritoneum. and aibastous. in addition, for eanear are prearnmc in Tabic 11 >n workers txpoird to aibeitsi ire ( the nak iistsamenc itetion of this inertaitd nak of taatromtaitmci canear. document. ai mown by ipt<Jcrmelo|ie itumai. Although eeio.rtetal eanear may ba Tha tobla icte forth predicted ixctn lifetime eanear riaka for axpoturcs of eursbit if dttactad in an tarty a tape, ona year. 20 yearn and 45 year*. Riaka other lastromtcatfnal eaaeera art for expo1 area ef t months are cioicty jiiuaiiy fatal. OSHA also btifevts that approximated by ene-heif the niks for aibattot mtpht induce canctra at other txpoiuru ef one year. Although evtrap: ittaa. which are also often fatal. Of that*. lunp eanear ecnttitutat tht exposures in demolition end renovation ere estimated at 10 f/cc. the table praattat health rfak for Amartean presents risks only for selected exposure aibaatot worker* and hat accounted for leva!* up to 10 f/ee. more thaa half of axcan mortality ut Thaaa ealeulaaoni show that the nsks torn* occupational cohorts. About tO% of lunp eanear patients die within 5 ef eabeatee-reitted diaeet* era alannmpiy high at current occupational year* ef diapnotie. Mesothelioma it an exposure levels, fat example, an incurable cancer which ia uaually fatal eatfmatid total cancer risk of 2S5 txeasi within a year after diagnosis. U ia dattha per 1000 workara axlata for tpidemioiopteally linked to atbeatee exposure. aad occure vary rarely, if at all. in perteea never expoaad to aabtatsa. Asbtstoti*. a type of pulmonary fibrosis. ia uaually non* revoreiblt. ita advanced atapea am disabling. and can b fatal. OSHA uneiudee that alt thaaa diaaiiat am very aenouc and that the exeaaa mortalily from auch aevere disuses mutt.be canaidertd in important factor far makinp 1 grave danper determination. 2. Doprae afRisk ofDtralepw$ . Denga/ova Ditaeta. OSHA bated its calculations ef extent of risk faced by workara under current exposure conditions primarily on the result* of a quantitative enalyeia which derived numerical mttmataa of eanear nak at *' vartoua cumulative txpeeuret eormpondinp to lavela at which workara ere exp*. ,*d (Ex. 5VM21. workara expoaad fer a 45-yter lifetime at 10 f/cc * level which currently exists a some eonstruelion sites. At 5 f/ec the exposure level* which are wandered evtrae* In ihlpbulldinp end repair, the risk of developing aabe*taa*ralattd cancer for a 4J-y*ar expeaure panod la 14S excess destha par 1000 workers. At the current permiastbi* level of 2 f/cc which also represents actual exposure leveia in such htdaatries as secondary fabricating at eament sheet, pecking geakets and paper products and rebuilding tad mfadng brake*, risk Is 1admated is M exeat* cancer death* per 1000 workara for a 4Vy*ar exposure period. Thaw'risks remain vary high when tha period of axposura far which calculations are done is ahorttnad to 20 yean, which OSHA believes it another appropriate point for ftminanon. The Although 2 f/cc it the current PEL for aabeetoe exposure. actual exposure period of 20 years ts the approximate midpoint between 1 year end 45 yean of conditions vary widely, mostly by txpoture: also many workers receive 20 industry ae^nent Aa explained later in Uua document and a* set ionh la Table yfers of axposura. Counterpart nak calculations using a 20-year axposura l. average ambient exposure levels in period are: for workara axpoaed to 10 tl various industries include high exposure ec 140 exeaaa eanear death* per 1000 levelsauch as 20 flet in drywell workers: far exposures to i ftos. 105 removal, renovation and demolition: S execs* cancer deaths per 1000 worker* f/cc in shipbuilding and rtpain mid* end fer exposure* to 2 f/cc. 44 axes** rasps exposure levels such ax t f/cc in eaneer deaths per 100Q workara. secondary fabricating of ccntani ihcot. OSHA alao animated n*k of packing and gatketa and papar producia developing eanear for a one ytar period and rebuilding and rcfucing brakast Id ef axpetum at various level* to which imponootMthttmaikmmtfiht f/cc far dry practicing of textiles: end employ*** art axpoaed. Tha counterpart toottotty for aMMiir mtoootoo to ant e trove dinjan alp r had at too (emphasis added) lower exposure lavaii iueh t* 0J f/cs end Od f/cc In the manufacture of floor tilt. riaka for exposures to 10 fIts for one year err IS exett* eaneer death* per 1000 worker*: to 5 f/cc 7 axcea* eanerr OSHA it damn at am iaetancM in Baeauaa OSHA ia required to rounder death* per tuoo workers and to 2 f/ec. 3 which expose** to a taxie whatance hat tha actual denser faced by worke-t in exeaaa etnenr death* par IOOO worke** more cieariy demonstrated detrimental aliening whether cxpoiur* to a Even at current workplnea rxpaiure health effects on humans thnn luu aubttanes presanta a "|rava dinfer". lavela which are lea* than tht current asbestos exposure. The diaroaea eauocd OSHA looked at tha nak nf developing PEL extraordinarily high n*.a ef by aibesiva txpuauraa am m Unyo pert . dtaaaae not only at the 2 flea disease exist. At 03 f/cc 17 axe*** Ufa-threatening at duabltng. Amanp permissible level but at all exposure cancer dtatha per 1000 worker* art DUP 0907219 DU 028320 31J3Q Federal Kes-*tef / Vot. 48. \a 2*s / triujv. *s<jh<.u*wv2 predicted Car * iS-year lifetime expoture. and 11 axeeea cancer death* par 1900 woman for a 21>ytar exposure panod. OSHA notes that tht ibovt atlmioa were compared to those in "control" group* no*, espoaed to atbtatoa or to mote of tonera I population* such a* U-5. stale*. Studies of auch denpn err able to provide direst heaurd. where the data tr* contulcrcd hath available and reliable. Tha nak ef exec** morul.ty eanm.iiru u a result of txpoaur* >o aionrnj m me condition* in the workplace today cj ieulationa art for ueaar nak only, la addition, a*bito*4xpofcd workers fact a high rjk of devcioptn/eibcetosi*. * disabling and often (ataTdiscaat. tttimutt* of tsecai risk. - Th studies used by OSHA in deriving dostuttponst rtiutfonihipa for us risk taattsmem covered a variety of work appear* te be aubeianuaily hiphor ihnrt other nska expenenetd by worker* from occupational injury hatards. Tht Ntuonel Safety Council (NSQ has Predictions concerning the estimated tituetiene end industrial processes- Tbit reported the annual death ratat in ttst msgrutud* of the ssbestosis risk have variety improve* the predictive velut of from work tcsidania ui a vtnely of bees perforated by OSHA and art the nak assessment because k lessees loduatne* (Ex. 44-139). Using tht NSC discussed is the nek assessment section or elbfunttcs the possibility that the data OSHA bae reviewed the annuel of ihia document. Accordingly. OSHA results west unique to any one mortality from work accident* per 1000 eaumettt that at 2 f/cc SO workera per occupational situation or were in fact worker* in several indsitn** in light of 1000 erpeaed to aibeato* for 43 year* aberrational. The occupational settings the excess cancer mortality from a will develop diaabling aebealoaia. At U studied were worker* aspoted et t (Ingle year of expoeur* to asbestos par f/ee for IS year*. it i* eatimated theI IS chrysolite textile plant from 1P3<M7J 1000 worker*. For example, in tha high worker* per 1000 will develop disabling (Dement et el. Ess. 3MJM and 34-037): rtak occupatietu of sgneuitur* end aibtstotts. Aabeatoaia (take eaa also be Canadian workers at an aabeato* (datnn-quitrying, the ennutl mortality eatimattd fonexpotuns for duration* cement facility (Flnkelateln Ex. 44-240): raus tram wok accident! war* 0.54 and ahoner than (S year*. For rxampk. the Italian ehrysotile miner* and miliar* 053 per 1000 worker* respectively m rlak of ditablini tabaaioaia from who wtried during 1IX>lHi (Rubin* (Ml (lx. 14-3311. bt cemrast. the death exposure to t.o f/ee for 225 yean ia U et at Ex. M-M): worker* la an aabeato* , nts from work aeddents for til eaaea par 1003 workan. OSHA'* cement pipe plant (Weill ef */ Ex. 44- - industrial combined wet 0.(2 per 1000 eeumata* of the magaitud* of (he 30*1; warier* in en esbeetoe production warfcem in INI. aabeatoai* nak are baaed ea aousd data plant and aabeaie* cement pipe factory OSHA bss estimated that the lifetime from pood rptdaaioio|ieal itudiaa. (Henderson sad Entarlina El 34-dl): risk for one ysr ef ixpetur* to 3 f/ee sf OSHA baiitvts. however, that the British worker* minofnocrtng esbestos asbestos is sbout 3 axcaas caacsr desths cortfidene* whieh eaa be placed In texnie product* (F io Ex. Oe-IM); per (000 exposed workers during the prediction* of aabeatoaia nak ia not at asbestos mine** and miliar* ia Quebec. renumber of tht worker* lifetime* (Ex. freaia* for the predietlea* of cancer Canada (Liddell et al. Ex. M-Hk and in 4-440).' Thus, ssbesto* worker* nak sf risk. This fa.b*eaaie ikt cancar nak tht Tbtilord hUaee. Canada (Nicholson exosss cancer mortality from a tingle Mtimataa an bastd oa a lartcr and - el el. Ex. 34-73): aad workan you of tipotun to 2 f/es Is roughly I mart varied data baa* end are derived maaufaeiuriog aabtate* Criedon * * Oats higher than tha risk of accidental from doee-exsrepoUtte* medel* that at* better eetibiiihed. Because OSHA ha* determined that tht riaka for cancer material* (Perry and Newhouae Ex. 44- 21). "Wall-conducted spidemiologic occupational faialitlts from oae year of caplaymen! la igneuiturt end mining- quarrying. alone indicate a grav* danger. the atudias that show a poaltlve association' . As shown in Table (. OSHA ettimatet additional ritka of dtvtlopuip aabtetoaia between an agent aad a diaetae are u not Boeeeaary is iueufy this ITS. accepted at the meal convincing . -that many worker* sr* exposed to aabeato* ia the vtanity of t f/ee. in However. OSHA hat eonatdered that evidence about human risk" (Risk addition. OSHA ealeuiaied the average the additionai and independent risk of Assessment ia the Federal Government txctia esnear risk to workers exposed developing itbeetciis increase* the Managing the Frame. National t condition* that txist to tha workplace denper faces by expoeed worker* and underscore! the pravtty of the health Research CouadL IPO. p. 21. Ex. 54512). today (for those above 05 f/ee and using the scenario described in Table 1). threats to employ**! poaad by asbestos. 1. Quality ofData a* Which MM Estimates an Burnt Tbs uodoriyinp data epen which the quaatiUtUv* risk aateaamtnti for aebaato* an baaed ere high quality epidemiologic studies, conducted to occepetienal environment*. OSHA eetpfetaixsa that tht data boat* lot asbeswa are of unusual quality and au*. Unlike moat potential occupations! carcinogen*, aabeato* has baaat studied often aad thoroughly far evahulies of it* effect* on oceupetieeel pepuiatmna. In denvinp thee* qaatutaitva estimate* lor eeeteet rtak. OS1 IA utilised eleven studios far the calculation of the lung caacer .jk. four of which were ale* ueetl to uicuiute .he mctotiviieeut nak. Invcaiipatians involved ~cnhott"piudi** whrr* the frequancies of various types of canurs in wotkar* espoaed to No extrapoiatisa from animal data to human data aecetaary in order to thaw aarcinogexiaty ef asbestos. For meat sabetances. OSHA must Infer humta health effects, such *s carcinogenicity, from teimel date. Tht rtaulu ef this nak catessment performed by OSHA agree wail with oXhxr recant risk casesamenu performed by ether governmental and euiaid* acwntiaia (sea Achaaon and Cerdnar) (Ex. 44-2(6 and 44-2431: ERA (Ex. * (gOfc Kang and Chu (Ex. oa-OOt): Sdikoff H el (M-CQZL and CHAR (Ex. 44-254). 4. Comparative Analysis. tnaight into tha magnitude of the nak associated with asbestos exposure can be gained by renewing ether eccupetienal nak*. OSHA bcbevr* it is instructive to compare asbestos nsk* with other workplace heard* agreed on as preseating aa unusually high degree of OSHA tsamatas that (0 axcen cancer deaths w ill occur per (000 workers for ( year txpesura: thus the avenge nak to workers (ixposed abort 05 f/eet lo tht workplace today ia approximately 20 tisM* the annuel fatal accident rotes in agriculture end mming-quarrying These companions ate striking They show that the estimsted nak of dying sf concur from asbestos exposure et levels xisting at the workplace today far txeteds ilia accidental death rata in tht nakiesl of industries. Although ttie estimated motiality mtea for ctnetr due to sebettoe exposure ere not completely compsribla to the total actual teudeatai fatalities, the review it dearly usefel in showing thit the magnitude ef the ubestot nsk ia grave One example of prtdictrd cancer ru* ea e mult of occupetienil expoeur* > the following cancer nak eatimated from DUP 0907220 DU 028321 occupational txpotura to iceiiing rndi(iof\. Th iicau cfle>r fatality ;i from 47 yv4f* of to iht maximum ptrmusiblt occupational txpoiurt to lomxmg radiation (t ranul it 17 to a pr 1000 worttr* (Commutes on tht Biologies! EllWu at tanixmf Ridution (BEiR) III frtdietions. in ( FR 1902). However. %ost radiation sitndtnti (tmiiiio OSHA tundordt) require that exposure linuu b reduced to tht lowut lovtl rasssoobly achievable btiow tht txpoiurt limit (tho ALAAA pnseiplt). Approximtttly M ptreoat radiation workers hove npoicii Ian than one-tamh tha maximum portmntd limit. Tht txctu eanetr dottha at one-tenth tht permitted level art v7 to 2J par 1000 worker* exposed <7 years. Atbotiet txpoturot 0/ ti yoan to 1 f/cc art prtdiettd by OSHA to ratult In M txcata eanetr dtatht par 1000 workers beginning wor1. at t|o 21 (lx. M-3B2). OSHA'* calculation for tht avartfo txettt eaoeor rUk to worker txpottd at conditions that txitt In tht workplace today (for thooo abovo 04 t/ee) for a tiyrtr txpoturt.IN txctto eanetr dtatht p*r 1000 workers. TWi figure u caiculattd by taking tht number of" eaoeor dtatht tttimattd from txpoiurt to axtstirtf eonditiana foe ts ytan for . those workers txpottd to granttr than >04 f/ee of atbaatoa and dividing by tha aurabor of worker* txpottd to atbtitoa graator than 04 f/ee (multiplied by 10001. Therefore. tha axean eanetr ritk at 2 f/ee tor atbtttoa worker* ia tttimattd aa mart than rwies aa high tt tht maximum ptrmitttd radiation eanetr ritk tad aboot 23 ttmtt hifhtr than the Mtunatad eanetr nix of 13 ptretnt of thr workert txpottd to radiation. At existing eondittonj. ttbtttot worktn* txettt eanetr risks tra tttimattd to bt 13 lima* higher than tht eanetr ntk fxead by U ptretnt of tht workart txpottd to radiation. The htk of tibntotit further inenttoo tht tignineanco of tho ritk from ttbtttot txpoturo. At 04 f/ee. OSHA Mtimoto* that 17 txctu etneor dtatht will oeeer tn 1000 worfctra txpottd il yoon. Thit ritk tt tpproximotrly 7 ttmrt higher than tha eanetr ntk (seed by M ptretnt of tho workers txpottd to radiation. OSHA (Indt that thttt wraptfalive ritka atrongiy atpptri OSHA*a Sliding that workers aiptttid to at conetntratiom abovt 04 f/ac art far abova the point nf atgnifieuin nak tad art at grsvt dinger of dying (ram eanetr. J. cJortuaion. OSHA'a (lading of "grave danger" ia board on evidentiary ami (Miliey eonatderiiliuns. OS lA't deiominttion that tht tnagnituiie a( tht p.-omutcouon of an CTS sitting a :.i wtnnatad risk to txooaad worker! ia alarmingly Sigh constitutes tht maior eompentnt of tht "gravt danger' finding Tht ovtrsil txtraordinary PEE may avoid S7IS eanetr deaiha illuming 20 years txpoiurt 10 aibriiei of ihe eurrent workforct tt current conditions and 711} eanetr dc.i'hi degrt* of ni*. the extant that very high rtak ia foupd in many tibeatsi using industrial, and tht unuiuatly high quality of the data atilittd to auks tatit (iiiiimtnti prtttm 1 vary strong tvtdtntiary bam for a "grtvoelangtf' finding, [uat as importantly, tht unique gravity aI (<btatoa>eauaed dlitiat*. in partieuLit eanetr. lueh aa mateihaiioou which ia linktd almoat axciuaivtly ta ttbtttot axpoturt. itroogiy aupporta OSHA'a finding of gravt danger. Alto OSHA'a comparison of tkt ntk of ubatos-r*iat*d ditetat to other iadur "tl naka undtneom tht txtr-.ardlatrtly high risk tatlmtttd for asbestos axpoturt. OSHA hat alto aottd tha concarat of worker* about currant workplejm eonditfont tad tht numtrous petitions far an STS from unions rtprtMnunf many expend werktrt. Finally OSHA hat raliad on ha txptntoea ia evaluating and regulating workplace haxardiia recognizing tht illuming S3 yeuri txpoiurt. OSHA If ewure. of count, ihai Section (e| of tht Act linns the tfftetivt time of ta ETS to I months, and OSHA cone/udta that t grave danger taitu and ta ETS it ateattary tvtn if OSHA rocuttt txciusive'y on thit tix month parted. Hewtvtr. the Agency beiievtt it it appropriate to etleuitta btncflu deriving from in ETS using lifetime nsks from 20 and 43 yetri of txpoiurt to tht PSt el 0.3 f/ee ttttblithtd by tht ETS. Althouga tht ETS txpnt withia 0 months. Section 0(e| request that rulemaking on t pernsnant tisndsrd alts bt completed within t months, to that then will ht no gap in protection for expend employees. In OSHA'i txptntnet tad judgment, complying with this statutory directive tnd completing ruitmskmg for t permanent tttndtrd withia 1 deaths of as ETS ha* and eon bt dont. txtraordinary dtgrat af ritk currently OSHA alts believes. bated on lu faead by asbestos workert tad in experience. that it Is very likely that tha determining that tueh ntk eanatituiat a FEL tftablifbcd after 6(bf rultauking grave danger to thott workers. will it na higher than 04 f/ee. tht El'S A AW formCTS limit Tfcartfera. OSHA baliavas that the ETS wflj ratult d t raduead lifedme OSHA hat drtarmfried that this STS It warktr txpotuni af 04 f/ee sr tower for ntcattary to prataet tmplayttt from 20 or 43 yean, and that tha benefits grave danger, tht second prong of tha derived from thet* exposure reduction* Act's last of OSMA s axarcitt of iu STS for these lime parted* *ra ipprapruttly authority (Suction t(e| af tht Aetf. At (ttributtd 10 OSHA'* promulgatisa of txplamad ta detail, tha afTtet of this CTS thu tmtrgtncy standard. 11 to tart many Uvt* which would a. Employee Cxpoeuret- Ts derive oihtrwiat bt loti to aikaitai-raUiad these niiniin of numbtra of livta ditttat if currant working eondlitont saved. OSHA depended on its wtra not changed. OSHA btlitves that employer can bt adequately protected against this grave danger only by issuing ta ETS. Thit it b'teauat no other Agtney tetion tad no other fortaatablt event would mull in sufficiently raduead 1 abettot taperurtl that would lUrviate the grove danger. Furtner. tht provitiona qfine ETS an tailorad to effect the neetttary txpeeura rtdueiiaat eqptditiouily. __ tiret Sored by luuiot on CTS. , knowitdgt of tht fellewtng ftetert: (1) The ampleyee txpetur* Itvtlt from :h ambient ttbtttot sir eor.etntraiions in the worfcplaet: (2) tht number of worker* txpOMd at tht vtnout aibcttot levels; (31 tht duration tf the axoeturt; tnd (4| tht probability af the ditttia (or the nak) associated with tht eumulam txpoiurt. Employee exposure itvelt art conventionally mtaaurtd in ttrmi of th.r OSHA hat tttimattd the numbtr of numbtr af tabettet fiber* thet tra 3 deaths avoided aa a result of an STS aileron* or mart in length in one eub-.t which would raduet tht PEL to 04 f/ee centimeter of sir. f/ee. In thtie term*, an (Ht 1 abitt 2 and 1|. For eanetr only, ambient eor.exntrution may item to be a bated an continuing txpoaurtt under wall amount of aibtitoa. However, m eurrantly existing eanditlona for f phyaieal terms. 24 f/ee aqualt ZOOO.'M) menths. the potential number of Uvea saved it immaicd at approximately 210. Based un continuing eapoaurat ai eurrantly existing eunditiona for t year, the potential numbtr of lives Hived it minuted at approximatety aid. Alte. fiber* per eubic mrtar |f/m*). Humam tnhuit about ant cubic meter of air oer hour, depending on dogra* of phixieal activity. Thus tt thu eonecmratinn. j worker would inhule roughly I6.txxi.000 fiber*. 3 micron* or more in Icneih. ever OSHA hui rttimmed that thu tn eight hour workday. DUS 0907221 DU 028322 f 1092 Ftiiattl Ragaur / Vol. <g j^o. rtS / r.-tday. Novtmbtf < I9R3 / Rules ana Kfnriqr, Naso.--Caaandmt an 'he mriurrwl prncsea. u* i# j<kliiium<l niinm fiber* leu ! i aiierant n Mrk m-y nu be 'ltheied. murmaf that pri ef eirborne einaatM fiber* tit ittt ike* | entrees. axampi*. ipaeifie report* war* found for iiuciiot cement manufacturing (F.x. S4:a|. laxtila manufacturing (Ex. aa-itr). ramovol of iprayad iibaatoi matin*! from.buildinga (Ex. M-2M1. and braka OSHA continues to me tha term. f/es. rtpair (Ex*. 54-2M. *4-29*|. Th* for Movtnitne* but (autions that the Asbeeto* Information Aiiooatlon numerical eatimatai 6f ir concentration* tivan in that* term* ir only eat way of viawutf asbestos eoneantratisn* nd should not b* evaluated without interpreting tfat meaning of the unit*. provided data concerning exposure* dunnt field fabncation and initillaiton of asbestos camant pip* and thaat in controlled condition* (Ex. 54-295). Tha Environmental Seiancaa laboratory (Ex. ta-0021 alio mad* bait animat** af OSHA atad txisting information to worker axpoaura m variou* induatrio* estimate worker b*to* exposure in forirs. t*di affaetad Induatry. Oat* aourea* "in addition. OSHA u*ad it* own field ineludad government contractor raporis inspacuen txpanane* to tatimitt (Lx. 14-002 and Ex. 54-0O*|. variou* xpeiures. OSHA ravtowod iiiactod atudia* reported in th* lltarature. NIOSH eai* file* and obtained information that Health Haaard evaluation*, and OSi IA compliance data (Ex. **-1451. OSHA raviawad th* information, and daddad liatad OSHA aabaato* maaiuramants durini compliane* tnapoetiau (root 4/1/ rp to i/ii/U (Em. *4-154. IWMl to mi th* 1110 Raiaardi Triangle Inatitut* (RTI) report (Ex. *4-40*1 aa th* primary baaii for expoaura estimates because th* RTI aatimata* appear to OSHA to b* th* moat camprahanaiva. In OSHA adiuatod th* RTI utimott aa appropnatt. baaad upon a gusli tativ* fudimant aa to which data boat raproaant existing axpoiura candition*. addition. RTI uaod a large number of OSHAi axpoaura aatimato* *r* baaad. different data aourept to raaka thair tharafor*. upon a aubitantiaJ data baa* axpoaura eatimata*. including ** and upoa cantidartblt experience tn Interview*. *xiatin| documentation. and enforcing tha axiaung aibesto* industrial hygtanc aurvap* of workatta*. atandard. ` Uaing*th* RTI report a* tha primary ' rafarane*. OSHA eomporad RTI data with other exposure information avail*bia for aaeh induatry. For OSHA aaad th* amplpya* axpoaura lovai* tn aaeh induatry to calculate th* " sambar of dtath* avoided by reducing th* axpoaura from currant level* to tha emergency PEL Alttmauv* expaeure dutnbuliont uitd far sensitivity analyai* will b* providao m ihc Preliminary Regulatory Impact Analyi i, OSHA beliavai that tha axpeeurt' tatimataa r* relatively |ood. gtven'`th# tata af th* art ef wonitr axpoiun * eetunattori taehmouas and data available today. OSHA ta not awara of any other available currant axpoaura aatunat*a. Industrial hy|itna rtpani ef operations in th# urn* industry, but at diffaroat work mat. invariably report differem aabaato* axpaauree among ir.e worktra. OSHA reviewed tht*e report* and mad* dadaion* regarding typical induatry practice*. For earn* operations, such a* brake itluung. several report* war* available with complete tleaaiptiOM af th* werkini tnviroamtm tad OSHA wa* ablt to ait that* to make direct axpoiura **um*tcs. Other report*. such a* "Removal of Pre-formed Aabetto* Insulation" (Ex. 54-244). dateribad careful procassas for atbtttet handling that did net appear rapraaantauv* af th* methods used throughout industry, suteo th* reported air cuncantratiant wart not eonaisitnt with ether report* ehowtai higher expo*liras (Ex*. S4-X*. al62). TbW# 1 show* OSHA'* asumatM af employat axpoaura ta aabaato* by Industry segment. auMiMn4M t % DUP 0907222 DU 028323 51094 <8Ffrdtul Reti..ef I Vol, So. :is / Kniiuy. SovursliiT 4 !4H:i I RutY* ,iru! KrsMc.u ur.* t w ( tllM K *1 I t f h r t t la|Mwr Is A lktfIM OUP 0907224 j : c- 7:3 DU 028325 Data from OSI (A s Management Information System |MIS) include* a lf(t at all atbettoa samples reported by OSIIA livid tuff during (tint 1.1179 lo Way 11.1043 I tv g*-3SS|. Ounnf this period. Mi eignt-ho* tim*'wigmtd average |TWA| surflet wera collected in many different industries. Of th Ml samples. 711(77%] ui below 0.5 ffee iso iia.4%1 fail between as f/ce and to f/ec and 52 (54S) wan above 2 f/cc. OSKA alio renewed the MIS summary report whara tha measurement data wan grouped within Standard tnduiirtal Coda (SIC) eJatlificationi (Ex. 54-1541. All thaa* data contributed to tha davaiopnant of OSHA'a baat exposure ettimata*. In conclusion. OSHA hat uaad its axpanane* in enforcing tha existing aibaatot ttandard ts datarmtna tha bast animates of woricar exposure in tha Industrial. On tha whoia. in companion to othsr touc subatanesa praaaat m tha woritpiaea. asbastos exposure information is wail reported. Civaa that OSHA axpartanea is eoastdarabla. OSHA beiiaves its astimataa an nasonabia and appropriate and provtda a lanifaetory basis for tudgmams^ regarding tha extant of nsk existing m workplacet. OSHA aeknowiadgaac however. that * tha axpotun mfortnauon concerning .' asbastos nateval and rtnevatfett la the eonstntetion industry is last certain than tha othar estimates. Despite unccrtainitias in ouaiifying axpotun in dta demolmon/rttsnvai eate|ory. OSHA feats that this baat estimate is based upon avidenes that is both nasonabia and tha hast available. Furthermore. OSHA believes that any ehanies made to (hr estimate as a result of tha uneartsinitias would not be of a sufficient mafnituds to warrant a chines in its basic finding*. 2. Calculation ef Uvea Saved end Diteete Avoided. Tha benefits provided by this ETS consist of cancer deaths and disabling aabastesti avoided. Tha estimates of deaths avoided by lowering of tha axpuaun limit by tha emergency temporary standard an based on the mortality rates developed in the risk assessment discussion. To genant* tha expected number of excess deaths attributable lo eebeatee in the UA. workforce, tha expected rate of mortality at each exposure luvei wet multiplied by 'he population exposed at that level. The expected mortality rata frum each exposure level wiis derived from OSI (A t quantitative nsk snsiyais (E*. 54-s:|. The expected number of deaths st tha rtductd PEL was than subtractud from the expected number of deaths it the current worker exposure lavait to determine the estimated number of deaths avoided by reducing tha permissible axpoaure litnit. Tha benefits are expressed in tame af eitimeiea deaths rather than disability because tha type* af cancer associated with asbestos exposure have a vary poor survival rata. An example of such s calculation follows. To calculate tha lung cancer death* avoided during on* year of axpoaura to a worker population in tha construction industry who sre tngagsd la ths mstxilsuon of asbestos cement sheet: Papula Uaa 17U (Table 7) Estimated Currant Expotura Laval 20 f/ee (Table 1) Estimated lung esnesr risk for one year at 2 f/cc* 144/700.000 (Table 17) 1. Calculate amactad deaths for Installers of A/C sheet having ona year of axpoaura at 2 f/ec exposure (aval: Population x ritkaexpaettd deaths (17tl) (744/700J300|244 Of . approximately three deaths among Installer*. 2. Calculate expectid deaths for btsiaiitrs of A/C sheet at PEL of0-5/ec far ona year of exposure: Estimated risk at 04 f/cc-St.l par 100.000 (Tabla 17) Population x risk axpaetad death* (17SSI (3*.l/10aOOO|wO.M or approxwatai. on* death among installer* 3. CalcJate lung esnesr dasths varied or lives saved for A/C sheet installers by reducing exposure to 04: subtract sxptctad dsaths at 0.S f/cc from those axpaetad at 2/f/ce 72441--(0 84) 14 or approximately two lives saved. ' The sstimuied benefit* derived from . axpoaura reduction* to several PEL'* which OSHA is considering for a final Standard ar* presented m Table 2. Thai* benefits represent the estimated number ef cancer uaathi tvoidud .'ram those expected due to 20 yavrs xpu..' at ihe eaum.iteC eurreni axcesuru icw's aasaming worker exposure ocg.m at j;e 25. The benefits wur* eaicuiuled using a base of 20 yean exposure baeau.se.'us stattd earlier. 20 yean is tn ssiim.tlc af typical lifetime exposures (or soma worker*. Exposure* of 8 months, on* year and *5 yam duration ar* lso used lo show tha grave dinger and tha need for tha standard, based upon a as f/ce PEL (se* Table 3). For Tsbi* t OSKA betas us raspiratar assumptions in the construction industry and shipbuilding Industry on its enforcement experience, on iti familiarity with tha industries, trad* muon*, and industrial hygttmtts. and on available studies on this subnet. OSHA baiiavat that that* astimatit may overstate tha digrt* of reapiritor uaa. This would lead ts underestimation of benefit* of tha ETS for tho following raaaon: Tha fewer workers in compliant* with tha earrant reauirtmtnit for respirator use for ambient axpoaura* txetading 2 f/ce. tha paatar the potential benefits, from an ETS mandating that workers b* burned regarding the significant risks from asbastos axpoaura arid tha important* of astna mpinton. Also, waritar* eturantlyusing respirators will benefit by further reductions from 2 ties to as f/ee. However, if respirator* mindstad by tha ETS are net used properly or consistently, than tha number of esneer death* avoided is an overestimate. . To tast tha rueuita OSHA also calculated the benefits assuming ths: til shtpbuildlng/rapair and construction/ ranovation/demolmon operations comply with ia* currant standard. All at tha shipbuilding/rtpair workers would thug b* pratteted by respirators wh.ch would reduce exposures to 04 f/ee. The construction workers would have an axpoaura of 2 f/ec. The benefits of raduetng tha PEL to 0.5 l/cc would, therefor* b* calculated as tha difference between expected deaths at 2 Vce and tha axpaetad deaths at 04 f/ce tar nil workers in that* segments. Tabla 4 shows that* benefit astimataa. sum one iiiwm DUP 0907225 DU 028326 51 CSS re<fcrl Rtp'aler / Vot 48. No. :i5 / Friday Nmemi.cr i. 19M - Ra,cl k 0s0 i40 t mm * i l * 3 *: v* 1I 2i k 8. wW * = 5^ *> R ~ 1 f f i, k 3 5 11 2 * m w I i!; i = i II I I i 31 i 3 j Jt--n "53 flfli! l! if! i S i * 4 -k it * I S i I ^s S *" S* SH*lj 4 s" s* *- c as aa {!i ii'i 3 <!: K ? if 11 U*l i! i i { 4-1 H i 5? *1 ;s ft fi II I! Isa 4i 1*3 31. V* MlZ + <4m0 Z* III S- Js l*i a* /s *l SM 1 2 s-1 4|8 II: . *S i25 !i* M ill |ti j 51 DUP 0907226 J J C 7S Du 028327 <8 Vo. 215 / Frid.iy, November 4. 1883 / Rules and Reguitiior.t s:ra Although tho results in Tjble I show fewer benefits OSilA believes ih# number of deaths avoided under this sesnorto. 00 for six month*. m for l year. 24:4 for 2D yean, and 1513 far 45 yean indicate * grave danger ind aeceikitut this ETS icuon. b Tthlo 4 \ Cancer Oaatns Avoioao aim 4 o.S f/ee FTS Actualng Coop liens* ten tna 2 f/ec Sttnatra + Industry Sector ( ewitn* 1 year Rriairy Nnufeeturing 2 a 117 Saconotry canuftetunng 12 21 471 Autseotlv* Afurn*r**t 4 a 134 Sh1pbuilding/*poir* 00 0 Construction** TOTAt J! ILL iota ao 1(2 241( 20 ycr* 45 y4rt 174 644 114 0 2441 3(13 *OSMA tstuMt tMt in* entire indwtry sector coopUei etth tn* 2 f/ce sttnetre through use 6? control* or respirators e4040 It of reducing txpotur* to O.S f/ee. *0SM atuMt toot tA renovation ad aonolltton Industry sector* trt arotaeSM to 2 f/ee by use of half oott oir purifying rospirttor*. 3. A/e Qlhtt A^sney Action Is Adtquois Ta Pretact Emsloytss Against This C/or* Oengtt. OSHA baliivts tfcot Congrats intended thot the E7S auiAonty may ba axareisad when OSHA dotansinot that a grove dongar la pratentad and whoa the provisions of tho ETS ore cref'ad 10 be an Immediately effective etean* of ptotaeiini employ*** agatnit such danger. OSHA. hawavarrhas tvolaulid the potential capability af otitar poaaibi* actions to radaea the nek from ubasiot exposure. OSHA kao determined that aa odier ageaey aetiea abort af taautn* tkia ETS which emnpdj an hemctliaia fourfold aepaaeae reduction will euflicfcntly protect amptuyor* agiwtss the grave deafer of developing aaUertae related diaoaee. la making this doterminatioo OSHA considered the uacfulnast of etepping up en/ereement of tho eunent oeboatoc standard. and initiating 1 Kb) rulemaking proceeding to permanently reduce exposure levelt. Tbaee aetiona wiQ be dispensed is turn. OSHA noma that these rotiana are not mutually anefuatwand la fact OSHA la both tupping up Ua enforcement octivitiea and embarking on o required Kb) rulemaking aa coordinated aetiviUe* in oddities to laauiag an ITS. (a) OSHA flrtt eaneludoa that merely inercaaing ita an/orcemtnt of the current aabesto* aiandard would net aufneienily reduce the grave nak of iibeetaa-related disease to axpeatd worker*. Even if uch tnataaed rnforcament reaulted in kemediotely uniform compliance with the current 2 f/cc standard In ill industries. ruka to atu**to**xpcs*d worker* would remain unjeeepubiy high. As stated bon. OSHA hat eaitmottd that at a 2 f/ee level employeea axpoacd over a working lifetime ef 4J ytare are predicted to have n axeata nak af dying from eeoctr of M la 1000 end of contracting diiaoitng aabattoaia of JO in 1000: amploveca exposed over 20 yurt us predictud to have exeaia cancer ruk af 44 tn 1000 and a diaobiing aibaitoata ruk of oppraxhaatoly 22 in 1000. Evan at expoearea letting eaa ytar. an aattmated 2 employees out of 1000 arc predicted to die of oiboataa raiotad cinctr and there la ilia additional nsk of dcvaloputg eahattoai*. Risks at the 2 f/ee Javti have bean acknowledged 11 unacceptable by other governments which hsve reduced their permisiiblt levels below 2 f/ee. To estimate the number af live* at stake if only the current standard were Immediately enforced instead of compelling a CJ f/ee level through this ETS. OSHA mode other calculations using certain assumptions about actual compiienet levels. Far this aaaiysw. OSHA assumed thot all construction, renovation and daaoiittoe operations eoaplywlth the currant standard to that worker* in this Induetry would hove txpetures ef 2 f/ce. Tho diffaranee ia the number of deaths avoided by coetpliaaeo with tho 2 f/cs standard composed with those avoided from compliance with the 0.5 f/ee ETS is lull vary high and ahewt that asbestes exposure even at 2 f/cc raprtsants a grave danger ta such exposed employ***. Table 4 seta forth tho results of lb*** calculations. Thus, for 0 20 year period of exposure. C'HA estimated thot moreiy tniurtng eenplianet with tho currant 2 f/ee limit may cost 2416 employe*! thstr lives. For ont year of expoiur*. OSHA esnmated that 162 employ*** may die If exposures arc net reduced ta 0.1 f/ec. assuming full compliance with the current 2 f/ss limit. OSHA believe* that that* benefits (l.a. lives saved) rtpftsant the lower bound ef those that would result from the ETS for two reasons. Half mask respirators which may be used at nr cancantrutiuru of 20 f/cc to comply with the currant standard may not tffrcmely reduce employee exposure below 2 f/c: Further under tho CIS. half mask rxapsntors may only be used m workpieces when concentrations do not exceed t f/ee. Employ*** m workplaces batwwan t and 20 f/ce must use men protoeuv* mpirntors under the ETS. tones, it is hktiy that ihtir aeiu.il % DUP 0907227 DU 028328 51098 rdfl g<?Tir / VeL 48. So. 21S / Friday. Sovnrrbtr 4. 1^3 / Ruins and Rrciljtionx exposures mjy bt reduced lo below OJ f.'cc end the benefits of die E1S will b* curratpondingiy increased. Further, an ETS by nuiurt of the aetioa tuelf. inti the secampsnying entar^meni program, wnl undoubtedly boot! t(e incentives to comply with all protean# provteioni of the iisaitot standard. [b] OS11A reteeted relyta| on merely be|iruun| Section Mb| ruiaraskin* proceedings to revue the standard to reduce the PEL a* *n laedeouate response to the grave danger faced by sbestoi-exposeb worker*. Beginning rulemaking procredinat remit* m no Immediate workplace change*. Employee* would Hill oontmue to bo xposed to theta condition* which dsfma g grave dsngar for at leatt the pendency of the roiamikiag. In OSHA'i experience. completing t(bl rulemaking* not mltated by an ETS conearmng haaardou* substances can take many year*. For example, the coke eves emission itandard took approximately JMi year*, tha lied itandard. mere than t year* and the eotton duet standard, more thee 4 ytsr*. Thete penoda do not include any of the additional dtiay* in the affective data* of OSHA standards* that ware due to judicially uapoaad nay*. whiqjt have malted te delay* lasting aeVaral year*. Under the amt fiverable eireumiuaea*. however. OSHA believe* that it te possible that e section 1(b) rulemaking limittd to tht issue* raised herein might be completed in approximately oae year, absent an ETS. Aa show* above, the astimatad ritka of developing ubaitowralated cancer due to axpetate for one year under earrant can ituanx. are si.!' axiraerdmariiy high. The additional risks of devalopiog aibaetasia due io ono ytar t axpoeart under curreru conditions, although guanufiad with (aa* certainty, an alio more thaa significant OSHA also tietiav** that tha naka of six month* t.xposare. approximatad by taking over hall of ti.a on* y*ar riaka unbar current coobitiona. alao an umiectptabiy high. OSHA ampkasite* aa stated abave. tha* Otl IA* experience tkow* that without an ETS. prouesdsngs laadiag te a permanent health itandard are *alikely to be eompkried within a ala month penud. The explanation of OSHA'i capability to product a standard within month* of an ETS lias in the urpeney genaraiod by OS) i.Vi Ceding id s grata danger, the exiawne* of a specific tututuo" dejUtlne to campiatr a ruiemakiae within I tnontli* and tlie need in prevent 0 a *p in pro;rRtionbctw*f the cxpirutum id ti.v h 1S *no the imposition of the permsneni iund.ini far a substane* already dotarmtnrd to preient grave Oangar. OSHA anu brlievt* that it il haipful to aviulata tht axttnt of mk reiujtmg from lifatima txpoiuri pertodt of ffl and 45 yt.in in tht abitnee of this ETS. Ai shewn in Tables 10 ind 11. then naki are extraordinarily high. 4. Other FactorIndiestinfa Seed for on ETS. Although worker exposure to ttbtttot hat been dtelfntng ovar tht yaara. OSHA beliivn that expoiurt condition* will continue to preient grivt danger In tht near future unleia to emergency itandard i* promulgated. OSHA baias this Finding an its valuation of cxpoiure information, asbestos use statisues. consideration of tha nature of Industrie! exposure today, and the degree of compliance with the current itandard. Although OSHA anticipate* a decline In use of asbestos in products, this dtdina will not maurially affect asbtstsa we m tha near future. The extensive tart littgi/.ion regarding ttbii'.ot and tht awartnns of haaith sfTactt associated with asbestos sxposurt providas strong inductmeitts for producart and iron of product* to wttch to lubititutai for Mbaitoi.-(n * fact, siheitoa consumption has dedinad over the ysan u shown: u.i Loasimptto* Ui Pattern (to 1*7$ 117$ 1*77 Ib7k 1*7* 1MB 1M1 1*83 m u $73 *l> Ml MO J4* za Worker uaiiestus exposure* will eofUinutsbowtxer. for many years in lit* future Uscauea substitute* fur toma products do not appsrur immcdiatily available. . Far oilier products old rrpluutnmt pnni will be nrcdrd fur many yrt. For example, automobile nwnufjeturar* may witett to nen.isbeetsa brutu and clutch fuetng in new vemeles m trie next several year*. Old vehicles. contmnmg .ibrstos parts, will remain tn h for msny ytar* thereafter. Paik at a), found' ovar half of all multistory buddiags turveytd (M eat of lift contained tprayed on asbastos material (Ex. fcu 2Si). The potantill for aibtstoi exposure exists as long n asbestos remains m the** buildings. Renovation work in tht building such is relocating walli and tlteineal wiring will mult m continued axpoium for corptnurt. painter*, tlactncians. laborer*, meet mttai workar* and ethers. Thsrefor*. OSHA does not behave that major exposure level reductions are about to oeeur In the near future. The trend towards redueben in asbestos use and asbestos axpoiurt hat bat-a a now gradual procaaa with the txctptien of insuncti where tht government intervened. For example in itn tha EPA banned us* of spraytd on mialatien containing mere than t pateant asbestos. Without OSHA sedng ot this tim*. OSHA predicts that the grave danger conditions will partial, certainly during bit ashed required for OSHA'i iisusac* at a Kb) stands^ and probably for many years thereaftar. L The Weed for the Specific P/xnuioAi of tho ETS. The provisions of the CTS require the employer to use any method of control to reduce employ txposur* to 0J Ifce end to tram workers coneammg the haxarda aisoeiatad with abesloa and procedural for reducing the nsk. These provtsioas'muti be implamenttd tmmadiatalv OSHA beiiave* they are greatly ntaded to afford stnployetrs meenmgfut proteetton At thi benefit itction txpUmcd m dttaiL competing exposure reduction! through an ETS will result in a great lumber of ttvea roved. In addition, as ttattd earlier OSI tA balievaa (hut its aitimetaa of tha Uugruu of eump'innet: with respirator reqatremrntt in the construction unit ^shipbuilding industry mny averft.iti: the dnpre* of present respirator use. Thus. OSHA may he sndmiattng the benefit* to lie derived from an ETS. ind henun the nard for such *n ETS tn be promulgatad. In additino. OSt tA'i Mtimutra of txpMuret in demolition and renovation aetrnnr.ts (if the Ronstnteiiun tndustrv are apofoxim.-it'1' OP f/cs. Sera under the KTS the CEI. i lowered to 0.S tier, tha airborne mncvnirutiun at whu.h more pmin tiw DUP 0907228 jv:707 DU 028329 Federal Regular < Vol. gn / Friday. Nnue-nhcr 4 \w j Kuict -no , resptraiore (with i protection factor IV. Ocoupatiaaai Haaitb Data fibre*!* is absent and du not seem to exceeding 10) must b worn drop* from 20 ilea (10 iiidm the former PH. of 2 (/ A. Introduction reflect :h* seventy of puirsunury parcnehymnl disease Pieurvi csl to S f/ee (10 times tlt now PEL of QJ 1. Atbtttotrtlottd Diteotct. ealeificatioa is also commonly found ;u f/eej- Therefor* QSHA btitevaa that Athettot esposurt etn cauic s number persons wno have been exposed to mart worker* wtll n4tr mart protrcttvt reepiritors under thvETS dun under th* currtnt permanait standard. that thtir actual axpoiur* lavela will b reducad to Mow 04 f/ee tad eensaquantiy that thtir n*k will bt reducad vtn more than the calculation* . Indicate. OSHA Anda alio that requiring t of disabling end fatal diseases. Among il.es* distaste are lung canctr. cancer of tht mesethaiial luting of Iht pieura and pentontum. and tsbastons. It ia also hkely that asbestos morasses th* risk of gasirointesuntl eancera. Of all iht dJatataa eauaed by asbatte*. death from lung cancer constitute* th* graatatt hatlth riak for Amartcan asbestos worker* lung evtcar has bean sbestus iCraighaad it n. im F.x.<*s0331. Asbestos!* is pulmonary fibrosis caused by the accumulation of asbestos fiber* tn the lungi Adverst effects of tabetioaia rang* from shortness of breath upon extrtien te eyinosti. e/Tutiona of serous fluid, respiratory failure, eardiae decompensation. and death. Ofttn. atbestona ti a progressive training program to be inaututad aa responsible for ovtr half of tba axcass disease, even in the tbaence of quickly aa poaaiblt la oca of the tneat mortality from atbaatot aapoaun us continued txpoturt. Symptoms of effective mathoda of stezietiatai the beneficial impact of the exposure reduction and of all the protective provision* of the current itandard. Thur. the content of thia ETS haa been diet at as the moat afTective short-term tira igjr to reduee aibeatoa rtaka which will be accepted and implemented. A Condition. OSHA Soda that woritrt eapoaad to aibeatoi in the workplace at existing txpattira ronditiona aaad thia amargtacy temporary ataadard to protect thacL from the grev* dealer prevented by .thaaa conditions. OSHA.finds Ua( by * xompellini a roducon to exposure to 04 f/cc for tkoto employ*** preaentiy ' eapoaad over that level many livee wtll be saved. Training iapaaed by tba ITS will eahaaea the ntk raduetiona. although quantification af that additional reduction amet be calculated. 0.3 t/ec ia the lowest feasible lava! achievable throuih thia emergency action, where short-tena implementation of the conuola i required. Only by iaauini aa CTS cuinpeUinq rtductiona in expotae* levels below the current permissible liaut af 2 f/ec can tome occupational cohorts. r - relationship between lung eancar trj asbestos eipoaurt has baan establiahad by aumaroua tpidamiologic tuditt of divarae group*. Asbestos* induced lung eancar usually hu a latency period in tacaaa of 20 ytsrt and stay b* diagnosed at tn earlier ag* than for non-exposed parsons (Craightud at ai. J9* Ex. 84-4231. Few cat** of lung eancar art curebi* datpitt advances in medical and surgical oncology. Only IK of lung canctr patients surma five or aora yiars after diagnaaii (Amartcan Cancer Society. \%*Z. Ex. *4-180). Asbestos txpoiun acts aynarttaticatly. with ciianite snsok* to multiply' tht risk of dtvaleping luag eancar. Matothaiioma alto haa bean* conclusively shown to b* associated with atbaatot by many studies, tn soat aabaetat-sxpotad occupational groups. 10*lt% af dtaths hav* baan attribulabi* to malignant mesothelioma*. Malignant - avaaothalioma* of tht pltura and peritoneum are axtrtmaiy nr* in parsons at axpottd lo atbatiot. Generally a latency panod of at least 23 to 40 ytart it required in order to observe mesotheliomas in an disease ere shortness of breath, enuah. fatigue, end vague feelings of ticxnesj. When the fibreeia swraen*. I'arresi of breath occurs even at rest C.-.s cumca! featu/a of tarty asbaitosis at weti as other lung diseases is end.mipiraiory crackles frtletl. Diagnosis of ssbastasit ia baaed upon the srtatnet of eheructtristic radieiogie changes, symptoms, rails, other clinical features of fibrosing lung dtsetse end a history of exposer* te aabetios. Cigarotie-emoxmg asbestos worker* may have an laereuad ntk of atbtttest* relative to non-amoking asbestos worker*. (Craighead tt aL 1983:Ex. 34-433). Soma tpidamiologic studio* have ebsorvad increases to esophageal, stomach, cola-rectal kidoay. laryngeal phoryngaal tad buccal cavity cancan. While tht magnitude of incraastd eeiteer risk for theta sites it net is great a for lung eancar and masotheiioma. the increased rtsk Is nevertheless of considerable anpenance because ef tht high background rates ef some of those tumors in tht general population. A W. increase in a common eancar such at colorectal canear results tn many more deaths than a SCI (natal* m a rart OSHA brinf abeul adequate roducuona occupational cohort. Some victim* of dancar. Colo-rectal canctr. if dettettd In hake. The administrative actioa of mtaotheiioma hava had a latency parted and trealid in an tarty localised stags, atepptna up anforcamant of the current standard is an inadequate response to OSHA i finding that cwraat ecmdiUaaa present a jravt danger. OSI IA does nor believe that any significant reduction will occxr within an acecpiubia time period withont thia etnaricney itandard aedan. OSHA has observed a gradual reduction in tacaedirii 40 yean line* ihtir initial exposure to asbestos (Craighead at sl im. Ex. II 0441 Thia form of eancer ia rsnty curable and it usually falsi within a.year afiar diagnotis. Then it no tvidence for a relationship between . etgsrette smoking and meuiholiomo risk. Asbestos txposure can cause pleural and/or other pulmonary disease. Pleural bat a five yqar survival rat* of about 79% (American Canear Social v 1983. Ex. 04-110). Surgical and mtdieal ireatment ia itat successful for th* other sttta Utltd above. Advtrst affcca from exposure to tabaatoa hava baan observed in wurwers invoivtd in atbaatot earnert pipes ana shingles manufacturing 'Emerimc si i.. 1873a. 19731c Waill at ai-1878. asbestos uaa. but hi the Agency's plaquta an on* tf th* markan of Finkalttein. 1812.18831 (Exhibits 84-122. aepartanea. stMBcaat and rapid xpoaure and may davtiop within 10 lo 8fe133. IM08.84-944.84-2401. tltirttot exposure redaenmu aaaaUy occur ia 40 years altar th* initial exposure. mlnm* and milling (Weaner et ! 1V00; response to standards. The provisions of Plaque* arc opsqua patehet visible oa iht CIS wiB aiqmficantly reduce the risk eheet X-rays that eonaiat of dense Liddell tt aL. 1877: McDonald cl sl im loW tt aL 188ft Nieholaun at *(.. ond rrtiuct it quickly. Thrreioru OSI IA fiMndt of etilUgcn (r.onftcetivo 187* Rubiat et at. 19781 (Exhibits 2-21. hat dettrmtncd that the CIS it protein) lined by meaothciisl ceil*. All 4-438.84-083.84-131 844372. M~0UG). neemsary to rrtieee the (rave duttqrr. eummerciiil type* of sebeatoa induce abasias textile manufacturing iDull. plaques. Plaque* esn occur evon wlien 1833: Peto et *L 19na Berry ct ui. 1978 DUP 0907229 JOG/ 5 DU 028330 51100 Federal Rctistct / Vol. <8. No. Jis / Friday. N'ovember 4. 1903 / Rules mil Resulstlons Cement et (I. (exhibits (4-040. (*- 14a. (4-030. (4-0371. insalution work (Selixofl et ii.. 19711 (Exhibit (4-090). shipbuilding (Ssiikoff et *L 1(71; Slot it it.. 1980: Tagnsn it lL 1M0| (Exhibit! 14-091. W-109. (4-1(2). efcl in vinity of iistiiot products murS/Cietunn; Industrie* (Ism* it iL IMOt Kindinoa ind Enteriin*. 1(7* McDonald md MeOonsid. 1971 Seidmen it ll- 1(7* Robinson it ll- 1(7* Aehston it iL 1811) (Exhibit! (4-1)1. (4-04(. (4-1M. (4-4S7. HUT (4-1031. It should b nottd that 2 fibers (<r cubic centimeter. which ii the current OSHA itiadird. ll equivalent to 2 m Jion fiber* pir eubte motet of (if. Because humim bretthe in about a cubic meter of ut every hour, dipindins on physical union, the current OSHA PEL far iibcttai illewt workira to inhale 2 million eabeiioe fiben per hour duha| to l-hour work day. For the take of brevity. subsequent ditcuenoo in thic preimbie wtii expreu exposure in terma of fiben per cubie centimeter (f/cc) rather than fiben per cubic meter. Keu--'The camat OSHA standard ladudai asbestos libers 1 nucrnniin er era in leneth. thereby excluding shettee -- fiben. Sioci ep te MS ef eirtMmi iibeitce , fibers era thenertbeaiaucnateicn. werken auy ichele ip te ICO eufiiea eebeuee iban per bear dann u Sheer werkday. Since OSHA'i publieotlen of a aetiee ef prepoeed rulemaking in 1(75. additional itudiee have confirmed that aebeetoe tzpoture eeueee a hi(h rick ef cancer. In addition, much mere eeoipiete date oo the nature of dott-niponH relationehipi for asbettea-induad dieeeiet era now available. Theee atudiei |tnerally indicate that the PEL et by OSHA in 1S72 is inadequate to protect cibeatot worken from either tune diaesie or cancer. The following esenciee and eiqinixattoai have reviewed the health date for asbestos: bitemadeaaJ Agency for Research on Cancer ((ARC) (1977. Ex. 14-3211.0.'iamxatioc for Economic Cooperation end Oevelepsetnt (OECD) ' (1170. Ex. (4-337). NIOSH (117* lisa Exhibits 14-334 end 14-031). Advisory Ceeumttee ef the Health and Safety Coraminton of the UaitedICiiigdoa (197* Ex. (4-221). the Chroaie Haaird Advtiery Penal an Aebeetoe (CHAP) (1903. Ex. (4-tatl aarf the U-* Environmental Pisteettoo Agency (1002. Ex. (4-1(0). AQ ef those troupe have concluded that there te a causal relationship between asbestos exposure end the development of cancer end non- malignant respiratory disease. N'lOSH recommended reduction of the PEL for eelMitoe te 0.1 fiben per cubic centimeter (0.1 f/ec| tn 197* In 1MQ. a lomt NIOSH/OSHA Aibeites Work txtnpulation models srt valid Croup stated that thtre was no level ef indicators of the existence of signific.int xposurt to asbtstes below wmen health neks. clinical effect! d.d net occur and Exposure date frequently ire not recommended t PEL of 0.1 fiben per eubte csnumctir (0.1 f/ee), based on the limiteticr.s ef current technologies ef available for workers exposed before 197* Where hietoneel exposure date ire tvtilebie. the date often have such aessunng nr ecoeentrinoai of asbestos. The 1179 report of the limitations u having been collided and analysed using industrial hygiene Advisory Committee cf the Keilth end Safety Commission ef the United technique* no laager to use er hiving been collected la ooiy seme treat of the Kingdom. hereafter referred te in this worksite at having been collected os seeboa u the UJt Committee, lid te the only s few occasions. Therefore, of reduction of the British standard for aecatstty, estimates ef dose-response sbettot to l f/ec for chrysolite. 0.3 f/ec bated ea epidemiologic studio* will for smesitc. sad *2 f/ee for eroctdeiiie. have fairly breed rtage ef uncertainty. Cuirsntly. it sopesrs that ths United Kingdom may lower the PEL for ehrytotiit to 04. L riluatioti ofRi$k. OSHA's first step in analysis ef risk ef disease hem exposure le t potentially hatsrdous agent is s qualitative evaiusuon ef scientific data. This eveluetwn tnvolvee reviewing human and experimental itudica to consider auefa tactccs ea overall study design, methodt cf data collection, biologic pleaaibility ef findings, consistency ef findings from different studies, (sapors! correctness . ef the esfomattoo. end other faetort as well at genertl aelentifSe lodgment. Subsequently, after s specific agent kaa been fudged to bo haserdous. the qeantitetiv* expoeuip-ertponae reletisnahipi between ths spent and disease can be investigated. The available date on air concentrations of the subetsnee er btelegtcal indices ef' exposure, such fiber contents within OSHA must axaama the beat available date on exposure-response lo arrive it s dstentiaeuee ef significance ef risk, despite inherent end inevitable uncertainties in the dote. The current (hour tune-weighted vettge PEL for eshettce ef 2 fibers per cubic centimeter (2 f/ec) envisages that werken will not native a cumulative exposure exceeding 100 f/ec-yeert (*2 f/oe x 10 yeen ef occupational exposure). For asbestos. OSHA believes that e number of studies suggest that increased risk ef lung ctecer. sibettoiis. end mesothelioma have occurred front cusuisbve exposeres niiaatsd u dose to or below too f/ec-yeers. - Wets--COHA typwe1y wee qyeetiu the eerted ef a hi werktae bfetaae ter petssees ef eiMaOfytag nsk (ram etsesun la toxic agesn*. Fesesbeetee. steey saenusu have aeed 10 yeen te rttreMM e fuU werfcme Ufeerae. TV**. bed a yeen ef 'expense ted M yeen ef expeewe era used lungs, can be reviewed for cohorts of le thie doemiu for dw yetpe** ef snetysutg warksn demenesreted to have ta dees raeyeeee raletiaasOiee tot eskesto*. instated nek of disease. If workers with an observed excess nek ef disuse hove rteeivtd cumulative exposure* permitted by the current OSHA panrmutibie expeeer* limit. then * potential tipifieant heelth nek from exposure to the PEL bee been established, if the werken wiih observed excess risk received cumulative exposures above those permitted by the current PEL. then risk from the current PEL mty be estiraeted from nek observed ct higher levels by uasng dose-response extrapolation models. The section. CgidtmioJosie Eiiatnca on Hitk from Zxpcturt at rat Current PEL will discuss the exteat ta winch toast nek ha* been atuorood from law exposures to asbestos. Section V. QuanutatinKUk Anofytia. will discuss the proJiettoc cf excess risk from lew ttbeeict exposures using dose* extrapolation module bused on etudict observing nasi nsk in humans. OSHA considers that both risks observed by studies end risks predicted by dose- In these studies. the cumulative expotene resulted from exposure Itrtit greeter than the current OS) IA PEL cf 2 f/ee for ea (-hour day. Far example, workers wke eccamuletsd 100 f/ee- yurt eeukt ksvs been exposed to in sver-.j-c level ef S f/ec for t period ef 20 yean. Section 143). below, discusses ths epidemiologic evidence for risk from low ixpesuni ta men detail. OSHA believes that a sigatfleeat health risk has been observed fee esmulativt expesune that could be sceumulsttd by worken exposed te no men than the present PEL of 2 fibers per cubic centimeter [2 f/cc). EatttMtM cf caaaUtivt txpoturt if* eppruximotions ef telel dee* raeeivtd by e worker during the penod of empieyarant Mvoivtng exposure to ebettoe. Cumulative exposures generally in emanated by multiplying the varying intens!tin cf exposure, men as the S-koor time-weighted svtrecs. by the number of year's ixpeeed. Most tkesrie* ef the mechanism of DUP 0907230 j: q DU 028331 Federal Re-jisier / Voi. an. ns / Friday. Navcmlnr 4, iwhj / Ra!><5 xnd suai careinoxcnem assume that the nsk of converting mpel to f/cc hits brm eonucta of th* amosite worksrs. transformation si Uf|t ceils to cancer cells inerts*** with increase* to tht suggested ss rsnymp from 1:1 tu 1J depending on tn* induitrv studied bv Presumably. family eaniuets received their exposure to tsbesiot from dust toui do**. Exposure* received after the scientists ikang end Chu. F-x. Put. earner) home on ihe werxer 1 coining, eeh * trunsfornuiionbas taken pise* Hummtd tt al. Ex. a4-277: McOnneld. especially during the laundering of dysti may >d the dsvelopmlm of eancer. out Lddeil. Clbbs. Evstan. end MeOuftuld. clothe*. Aliout 10-fold mervsse in ' have not caused the cancer. Thu*, ut Ex. 44-06J|. For eaampla. unnp prevalence ot pleural thickening some mstsneii. annj Fetal eumulsdvt conversion factor! al 1:1 to 1.3 * compared to centrals wa, pbtarved in txpoiurt m*y ovtiitate the xpo*ur*s e-jmulstiv* exposure of 20 mpcf-yrir* famtl) eoaucts of workers with only suiTiotat to produce meretttd cancer could range (ram 20 f/ce-yeors to 100 U on* year of axpotur* within the imoine risk. For the rotten, soma ce-yeerc. factory. epidemiologists omit the later year* ef Tht hush Occupations! Hygiene Estimated asbestos exposure levels of exposure to arcraogtn In analyse* *f Society Commit** an Asbanes family contacts and community atoneitty in ttistioe to eumuiatfv# conducted a study of dw( members observed to be at risk of exposure. ooncontrations measured by current asbestos relattd disease have not been In addition ta cuctuiativ* exposure. methods sad hiatancal methods (Ex. M> reported. OSHA considers ft vary likely imtntity of exposure can b* examined 024). Convamon femora for historical that th* cumulative exposures ef the ta telauen to disease. Inleastiy el method* to currant methods war* t: 0.07. family comaett and community exposure is often approximated by *hour tlme-waightad lungs* (fWA'al. Tie OSHA PE. 0/2 liber* pot cubic l: it and to, dtpeodinp on tho historical method For astestoa aiming and milling, this ambers were lets than too f/ee-yttrs. Widraan. Selikoff. and Hammond (Ex. M-OI7) studied th* mortality ef 120 oeminttter (2 f/eel * an (.hour TWA has only been tn effect since 1FH. At this tires, it doe* not appear possible to determine whether intensity of exposure ha* an effect on disease nsk separate bore that of cumulative exposure. This la because the current OSHA PEL ha* been w effect only sine* 1971 which is aa loiaffidant period to observe ~ asbestos-related dissent, which charsettns&csiiy have lent latency peneda.(ta ixetss of a year*). Aa .dtaeuntd la the section. Quotuttiooro ' EJtk Attaints, it appears that dunnoa of exposure may have in mdependtnt efftci on masotbalioeta nth. The fotlowini saction* anaiyes recent epidemiologic and txpenmental trudits msd discuss Important aspects ef (he aocupatioael health data concerning aebesios. taction will us* tht midpoint of the rang* of conversion factors: 1 mpv/wj U cm For asbastce production and atbeato* oaaent production tht* taction will use Hammed *t sL't suggestad eonvtrwop factor of 1:2.* for mpef to II ec 2. Epid - - '9lie Studios. Tht epidemiologic studies (hat OSHA Interprets as suggesting that significant health nsk hat bees observed at lew aabMtM exposures fall Kite 2 , categories: (1 j Studies ot household coaiacu of asbestos worker*. (2) studlts of worker* when txpesures were short* term, and (3| irudits of workers with emulative exposures estimated ta he dose t* or below too f/cc-yesrs. This taction suaunaftac* tkase studies sad * presents OSHA a anaiyita of then studies. amoait* production workers employed totnattm* during 1441-43. Seidman at at. raportod that dust eoneantratlons htd navsr been maatursd In this plant and that th* plant was known to have deficient ventilation system*. Workers wore classified at having worked lass than t month. 2 months, i-t months. S22 months. 1 year, or 2 or mor* ysirs. Workers in all categories of length ef employment hid excessive mart*dry from lung attest. FtruampI*. man impioyed las* than on# month had a lung cancer standardised mortality ratio (SMR) of 207. baaed 00 supplemental autopsy. clinical and surreal Information. (Th* standardized mortality ratio (a calculated at th* obtarrvd naaibae of deaths in the exposed population divided by the number of daaths that would be M. Epidomiologie Evidtnet on Aitk from A number e . .udies have obtervad Etpeaura at tho Currant PEL mesothelioma* and an increased expected tn the exposed population, based on mortality rates of sn 1. Copvonios of Ponielo Counts to Fibor Counts. Currently, personal asbutos ttatple* of exposed workers an colltetsd vnth a membrane (Utar. > >'* fibers art counted atuia a phase eootrut auereacope equipped with in eyepiece trsticul*. in tho put. paittein ware counted rathot than fiber*, area aoetpie* ware taken ratter than pertone! sampiai-and tampla* were collected using thenoai precipitators os midget lapittem. Tteao post industrial hypotw maataremanf* weep axprateod tax miiUosa of penid** per cable laot (obheeviotad at mppd tt rnpeff. where** umti measurements are expressed ta fibers per cubic entimattr or per ftaUifilsr (f/cc or I/ml). Coavtittion ef moMuramentt ham apet to f/ce is not simpt* matter of applyutp a ample multiplicative (actor duo to tk* differing work environmem* tn whteh samples were taken and diffeflnp sampling methodologies. The (actor far prevalence of chest X-ray abnormalities among famiJiaa pf atbtste# workers (Andaraon tt al. Exhibits W-Otl and *-017; Vienna and Poiaa. Ex. aa-lM. U at al. Ex. SO-1491. In sddiUan. matottelismat have been observed in eammenity members livtng near asbestos a;ne* and (aments (Wagner at al. Ex. 2-22. Newhaun and Thompson. Ex. PS-OTb). Aadenoo at al (Ex. S4-C1S) observed "* a 1M perctnt prevalanca of ehast X-ray abnormalities. inciuding pleural ttueiaaing. plaques. pleural calcification. and irregular opacities, among 130 household oontaett of aatotiw (actory workers compared to a <J peratdt prevaimet of chest X-ray aboormalitivt among 3a controls drawn from th* tarn* community a* the amotttt worktts. Control* wet* matched to th* cates by ty* end *#*. Aa oC2g7f. 4 eases of snaarwhalioma had been diagnosed tmong the (Jl family sppropnst* comparison oopultuon. Tht SMR Is frequently used st tn approximation ta tht relative ntk.| Hence. OSHA considers that Seidman et aL demonstrated that exeass lung eanetr nsk could be expeneneod tvtn by woriara with exposures of nisuvely short duration. letry. GlUoa. Holmes. tewinsohn. and Reach (Ex. S4-C20I studied the workers ef tn ttbettet textile ftetery m the United Kingdom. Berry et *1. reported to in that the average exposure lev*) was S f/ce and that 6.S percent of men employed tftsr 1950 had -postiU* etbettotis.' Among men employed efter 19J0. lerry et al. observed 2 percent prevalences ef crepitatiaaa. "possible ttbtttetis ' nr `'certified asbcstosit" *1 37. 8. and 81 1/ ee-yaara mpeettvely. Berry tt aL concluded: "In view u( theta findings there is no ream for complacency about th* 2 f/em* standard OUE 0907231 J 'Q DU 028332 5U02 Federal Registar / Va|. 48, Vo. 213 / Fridsy. November 4. ,983 / Rules nd Regulations md effo'ts should b continued to reduce sabestat dull to i low a level u possible. At this tugs it i impossible to tut definitely thst th* standard n inadequate. biciuM its introduction n io recent. md it it esionual to follow up groups txpeted to lowltveit In order to improve itit data nec*$try .or tht formula uon of better sandarda" (Ex. 8^ am p. tot). Fmkilstain {Ex. SS--04-41 studied ih* development of eoapaatabJa (earufiadj nbnioiu among 197 Ontario aibaataa eamant production workers in relation to cumulative exposures (f/ee*yatn|. Ail worktn in tha itndy cohort bad at laait IS year* of exposure. Ontario entana for certifying aabaatoaia. which roauiu in tht award of disability pensions. ara flat innaxibla and involve eoniidaratien of toeb factor* aa biatory of occupational exposure*. dyspnea, crepitations. dubbing of fingers, radiographic signs at pulmonary fibrosis. and abnormal lung function. Certification of aibaateaia banco would occur at an advanced stag* ef disease. Each produedan warher wu cJatatfiad as bavtitt roeetvad 0-41 H4i 100-141 iso-tsa. or 200*240 f/ee-yotn w eumuiauva exposure within the it year* following initial axpoaun. Ftnkalsieia ctlcaiatad lnddanea ratM donaiitint af number of new caaaa of demtfiad aaboototio per 100 ponon-yooro at risk. (incidence ia the rata at which now eases of atbeateeis develop m a given penod of urns. It is a dtract maaaura of tha mb of devsloping tht disaaaa.j tncidaaea totaa wars OS. S i. aod 0.1 for werktrt who rtcoivod Ml 10-01 and 100-141 f/cc-ytart ratpactival'' 'iabalitaia also calculated tha eumuiauva probability of having developed esrufitd aibtiteiit by tha and of 32 y;*n of iataney. and obiorvad that man m tha 0-41 SO-SO. and 100-141 f/ec.yaara categories had about 10 pareanL SS percent end TOjarseat probobilititi rnpaetivaly. Duo to atsaQ number* ef men in oaeh eatofory. these catunatad probabilities had Radi itaiiatical uneertamty. Finiielitam ataiad that the uaesruuuiaa m axpotura eutamaata and tht selection Wad ariaint from exclusion from the atady.pt wurkars with loot than IS years af ampisymaat may have lad is evomttmaboo of risk at low exaeesras. which was "to soot* neat balancad by tha (act that the and point w dudied was ocrtiBad dnubility, as advanatd aupa at isbestou*' (Ex. 14444. p. SOtV OSHA eontiden that Fmkcietain't finding* of tact** mk from lew cumulative exposures are very important bnuauoa Ihe outcome. cenifiSi ssbesteau. was baud upon lubrtantnl medical evidence of icvire ditubility from ihe disease. Osment end eollet|uee conducted a detailed itudy of plant proctiiee and duit control methods at a enrytotile textile plant during 393<MI7S (Ex. 8403184-0371. Exposure histories were coattrusted for each worker and estimates af individual eumuiauva expoiuree in terms of f/ce-days were made. After 1*40, exposure laval* ueiialty ware in the rang* af S-tO f/ec. Warkara were eategenxtd t> receiving rxpoturei af lest then 1000: JO&MO.OOCt 10.000-40.000: 40.000-100.000: ami greater than 300.000 f/es-daye. hum Dement at sL included holidays and watkands in ihair estimate* of f/ec* days, their eidmataa of cuauiativa expeeuro art Itktiy to be everetated. OSHA eaieulatad that Oamant at aL's catiiortas af f/ec-daye are routhly equivalent to leu than 17:17-27 4: XT 4- 1004:1004-374. and greater than 274 (I cc-yaan of occupational exposure. Kota became Oemest et at esuawd baiidayi end weektadi tor tSatr calcuiatiana af f/ee-day*. OSHA i n4sd f/cc-Caye by 341 is amve et ettuutce W f/u-yean. Dement et al-'a flret 3 expoture eatsgone* fail within tht ruga af cuauiativa exposures pormitttd by-the ourrant OSHA aabottot standard. - Among white make with IS sr more yaart aflattitcy. iuag caneat SMftt were 140.37*. and 332 in tha esttgnrtoe of leu than 1000.1000-10000. and 10400-40.000 f/es-daye respectively,' The latter 2 categertee' suttees of lung cancer wart etatiaticaily significant. For pthtr flon.maiignant reepiratory diseate (excluding both tn. tious reepiratory distaste and brenchitU). tha following SMR't ware obitrvad for white males with 1* et mart yeart of latency: M2 for man with lest than 3000 f/ee-daye. M for aa With 1000-30400 f/ee-day*. and 879 for man with 30400-40.000 f/ec-days. The axeaaiaa ware etauetieaily eignificaat for both tha firtt and third category of camulabvt axpotura. Damans tt al concluded: "Saitd an data from (hie itudy. ngm/ieantly alavmttd mortality r.tka ara predicted far lung cancer end far aebtttosis at camuiativt expoturn ef ICO ftbare/ oaxyeart in tha tsxtiia industry" (Ex. 84-037. p. 432). OSHA esnsidart that Dement tt *L> efaaervutiena u( exeat* nek (ram low cuamisuva exposures ara wailsupported because of the careful estimation el exposure histones fur the cohort. ttendemmsnd Enlarlint (Fju 84-041) limited the mortality uf 3078 atbeetoe production workun who retired during 1941-1987. Mortality wee observed during tha period 1941-1973. Cumuiutivu exposure*, expreeied tn milliont of particles per cubic foot of air times yran reposed (mpef-ytariL ware titimated for rich man tnciudtti m tht tudy cohort. Mean axpotura* for 8 cumulative expoture categories were 82. 382.392. 80*. Md 97g mpef-ytars. Hammad at al. (Ex 84-277) euggeitad a mpef to f/ec eonvtrtion factar of 3:1.4 far i eamant pljut Because eamtm end ether tntneral partdei have bean axttnaivaly used in aibtttea products manufacturing using a conversion factor af 1:1.4 data aat appear to ba unreaeonabia far Hisdtrton and Eniarlina't study cohort. Using t factor ef 1.T4.12 mpcf*ytin Is roughly equal ta tr f/cc-ytart. A reaptratary eanetr SMR of 197.9 wot observed In tha cumulative expoeurt category with a main txpoaure ef 12 mpef-ysars. Thus. 09 !A views this study as having ebtarvtd axaaaa risk af dying frsm reepiratory cancer among an receiving eumuiauva expoture* permitted by the currant OSHA PEL Using a eenvtruon factor of 14 would result m an estimate af cumulative exposure far tha lew exposure category tbit la about 90" higher thaa that tnvtiagad by tha WTWt OSHA PEL Damaat at ai. cammeatad on iha marked diifmancaa bttwees the studies af Damcm at aL and Hadarten and Eatarilaa with regard to risk observed from low exmuiabve txposuret (Ex. 84ear). Oament el eL wcgesied ihei these diffwoacM may ba attributable to the fact that Headsmen and Enttriint studied retire** 09 yttrt or alder, with thas* retinas constituting a saiact group of survivors. Only I of ths 39 lung cancer deaths observed by Dement rt el. occurred ia parsons U or older. McDonald. Liddell Gibb*. Eyssan. and McDonald (Ex. 94-081) studied tht mortality uf 11J79 workers exposed to ehryaaUk mining and milling born dunng 1191-1930. Mortality was obaarvad during tht period 1910-1*79. Each worker wss dasurud et having accumulated lata than 30.30-299. or 100 or mare eipcf-ytart by aga 49. Using s canvanion factor af 1.3 for mpef to f/cc tbes* groupings would correspond to last than SO. 90-899. and 900 or mere 1/ ee-yaars. Lung cancer SMR s were 93. 118 and 238 for tha 3 categories starting with lues than >0 mpef-yaart respectively. Shift's for pneumoeemotit were 2DR. 10(1. and 8400 tor sumuU tn e exposure ealefene* of lest than 30. 30298. snd 200 or more mpcf-ycars. I trnr.c. McDonald tt sL did net observe much lung cancer nsk but did observe an DUP 0907232 DU 028333 >. ;nwi;ar ig'iihtgTnri'gLIlL-sag^gS'i Register / Val. as, N,,, y;S / Friday. Novtmacr 4. ioaa f S,,im .aa rtts-ui.n.ons <41V< Increase in pneumoconiosis rtk m ih low ssposur* category. yam wars U4. 2S.I. *. and IS for conditions md meu.urad dust Croupt A. B. tnd C md for Ontario mtn concentrations during (hast iimuiui.ons A eese-control analysis used similar retpcctivdy. Approximutt relBiivt ritfct in ordtr to make mors seeurait txposur* categories: however. tit* for Croupt A. 8. and C. aa compared to tiiimaiet of axpoture during pcnnui analysis was imnnsieally ineapsblt of Oniario man. art IS. 15-3. end 14 for (pre-19CSI m which axpoiu/at wert net ' observing n txetix r*k m tht leu than lung eaneat mortaiiiy Gisiroimtstmxi mtaiurad. Mean csncamrctions uf c 10 mpef-year eattgoryliecautt tht eanetr mortality wat alio elevnad in libuiioa wart tiumaitd to range uii to controls Bud itio bettgenrysotila mincri Croups B and C relative to Online men. 30 f/cc before JJSO. tnd millin. Tha lung canetr mortality ratal did Compared to Italian malts, the ovtruil Regarding tht different findings on lung cancer nek from low exposures not csnaiaiamly inertias wi in1* mertasing tstimttu of cumulative eohnrt had sttiittically significant tscawtt tf mortality bom laryngeal between tht studiee by MeQonald tt tU axpoaura in that Croup C had tht iowtst cancer, nan-malignant ratpiratory tnd Dement tt tl. Dement tt el suggeittd usprtation of axpoaura lung unctr axeatt. Finkelsitm tuggttttd aavaral poitatltl distant. tuberculous. eardiovaaeuiar diseases. arrhsia of tha Jivtr. and ttnmtttt tnd difference! m urbomt explanations. including inaccuracy of aeeidtma. Lung unctr mortality was fibtr eharaetariines it possible rttttnt axpoaura claatifiutiens. atanatical alavatad only slightly (SMR106): for tht differences. Otmtnt tnd Harris fluctuations rasuiting from tha until lisa however, there wat soma trend of previously htd found that ttmtilt of tha cohorts and esafounding affaeu increasing lung eanctr nik with processing produced a higher proportion af smoking if than wart diffaraneaa tn Incrttting length af foilow-up. For of lsn| tmn fibers falling within tht amoktng habita among Croups A. B. and example. tht SMR for lung eanetr mi rangtt dtlinttttd tt etretno|tnte by tht C. Bauuaa a consistent dose-response 2os during isn-trj. tmrnal ituditt of Sttnton tnd was observed both for mesothelioma lacauaa all analyttt of montlity m eoUetguss (Sat Stetton E(3) btlow. mortality tnd ubaaioait in tht study raJaiion to cumulttivt txpoturt Cipanmtntal Octal. Finktlmin {Ex. *4-2401 tlto ttuditd mortality from lung ctnetr. mesothelioma. tnd othtr ditttttt tmeni workers tt tn Onttno ubtitot etmtnt factory Httblithtd tn 194*. Tht group. Finktltittn tuggttttd that tha axpoaura cUtttflcsuent may have been comet Flnkaitiain concluded that lung eaaear mortality rates "may bo railed several* fold" (Ex. *4-240. p..143] 4t cumulative eantitttd of companions among ihe cohort msaben. rather than betwtan tha venous axpoaura subgroups and Italian aulas. theta analyttt ware incapable af detecting excess risk In the lowatt cumulative axpoaura category. ttudy cohort eonaisttd of 339 man hind btfort 1MO who had bttn tmpieytdLtt tht factory for t yttrt or mort. Each cohort member wti classified tt having - tdeumaUttd 4-49. ?9-12V. tr 122-420 tl ' cc-ytari of ubtitot txpotort within tht exposures of 100 f/cs-ytart. With regard to gutrouuttnnai cmcar. Finkalaiam fudged that no firm conclusions could be drawn due to tha small number of deaths, although Ultra wta a trend of increasing risk with taenasbig Theta analyses ware eapabla omy of detecting trenda toward increased nsk with tncreaaad axpoaura. Although tha exeats lung cancer rtskfoddi ratiowZJJ) lit tha high axpoaura group was sot statistically significant. Rubino 11 yttn foQtwtnt initial tipotun. Thin tipotun eaiejenes. htntfttr rtftrrtd tt u Croups A. 1. and C htd cumulative axpoaura. Mesothelioma death ratal wart considered by Ftnkslaitin to be related to cumulative tt aL considered II "likely that tha Increasing mortality truly redacts the fftete afhigher axpoaura* (Ex. W-OM. the following mean emulative exposures rttptcuvtiyi 44. t2. tnd lhO tl ca-yeart. Croupt A tnd art low expoturt groups. Mortality by cumulative expoturt was anelyxsd tttntnt X ytart tftar initial expoturr. to iha< tht uiandar period during which deaths ware observed ipaantd Cohort mortality wit compared to that of Ontario man during iSro-ttra. Agt-ttandardiscd mortality rotes per 1000 oun-ytart for ipteifie eauitt tf death wart cemputtd for Croupt A. B. tnd C tad for Ontario men. Thus, this study did aat have tht bluet from confouadms offsets tf t|t that can occur whra SMB's art being eomptred among parent groups of workers (Sat Ex. *4-1351 One puttntul problem it that lust unctr mortality may have naan tn Ontario during 1979* IMOt this would retail in toot undamtintstios af aoanporiaost values end henct tome everasunutioo af lung cancur nth. I lowrvat. this ovanttunatiM of risk likely would 1m light. Mciothelinmu mortality rutrt prt 1009 axpoaura. OSHA believes that Finktltttin't ttudy presents atndtnea of txeess lung, cancer and aiatolhtiioraa risk (ram rtiatively low cumulative txpoiuns. namaly 44 and tl f/cc-yaart. Lung eanctrrukmt- have been somewhat undarttiled by Flnkelttetn'i axdutlsn of lung cancer daatht which occurred before 20 ytart J follow-up. Kubino. ftoUuo. Nawhouta. ScanteitL Aresba. and Murray (Ex. *4-0001 studied tha mortality et *12 matt Italian ehryteul* miners and nulltrt during 1SM-1VT3. Mortality from respiratory distaie tnd other causal af death. but not from lur.g cancer, was txeassivt in this cohort Criteria for inclusion m the , study enhort wan turvival until lanuary L lt4C and at (vast one month of employment during lMIMthS. Comparison of mortality was made to age. calendar period, and cause-tpectfic mortality rates uf Italian males. In addition, mortality rates ware compared among tht. cohort members using c cats* control analysis and historical prunpuctive analytic. The cumulative p. 193). (Tha odds ratio it an aatimata of tha relative risk dtQaid aa tht ratio of tha adds at dying from eanetr in tht axpaaad population to tha odds of dying from cancer in an unexpeted population.| Rubino tt.... ttudy is unuiuai m nsi finding a higher lung eanetr nik among wotkara exposed to rtlativtU high (avals af asbestos. OSHA haliavas that tha irtnds of inertsung lung eanctr ntk with bath meeating length of follow-up end ineraating axposurs are continent with aa asbestos etiology, however. OSHA alio belitvts ihai tha hign ntki af mortality from othar eauitt iueh vi non-malignant respiratory disease might hive obseurad lungexnerr ruk. eipodally ainea these high risks appeared within the first 19 ytsrs following txpoturt and asbestos-reined lung eanetr generally has a longer laitncy period. Alia- OSHA euieuluivd that this atudy only had 23.S~ power to daiact a 50" inereasa tn lung exnerr risk among workers with 20 or more ye.ns of follow-up. * man-ye.iri for Croups A. II. anil C were fiber exposure wat etiimuiud for each Now.--Clai is Ill'll power auuniifu-t ih'- 1.1. 4.9. and 11.0 rwqwutivi-ly. Uuiv caaerj mortality niii-s per U9<J man* worker in irrmt of f/ee-yeara. The invptligaturs nmul.iied pail working lulny of study is detect true mrri-.iM.-l ruk of scrolled mssantwt and rcivfi >u Hr DUP 0907233 . .- -a n J - < t. DU 028334 prsbsbitiiy of not inti** I 'rut ni. Coeraily. it it ftst4r^ wtitiwi for iiudits to htv* it lint nre pewar. IcetiiM lung csncsr n i tHitivily csmaioa caoetr. rpioamtalegie nudioo ibottlb btt i! Lhm to* x<*' > 4t*ci KTS xtnra m nik at lung eanetr. W Ex. IWX (or * dotcrlption of OS11A i twined if cakiAsimg pr. W*tll. Hugh**. and mggtnspiek [Ex. u-206) invtittggltd txpbsurt-rtipons* rtiaitonihips botwaan rtspirptory eanear nik and oxposuro In an aabaatei eamant plant Waill at al. did net ebsorva txeass nik amsn| man with lew euaiuUdvo oxpotum A total of SMS nan with at laait to yaara of latency tinea Krai exposure in aither of Z aibeitoa eamant plants war* iludiod. Ail mm had at laait ona month of tmploymaat bafora 1870 ind thatr vital itatui wai datarnunad aa f December 31.1871. Each worker'* cumulative dual exposure during tha 20 yaara from Initial axpeiura wai aitimatad in tarmi of mpef-yaert. Mm war* classified in me of S different cumulative expeeure eatagoner 10 or fewer. 11-10.11-100. 101-200. and 201 ar more mpef-year*. Uiin* tha eonvemtoa factor af in.4 suggested by Hammad at at. the I cumulative expoeure catetorim would,, be equivalent to 14 or fewer. 1V70.Ti lda it1-2*. and 211 or mere f/oe-yaan. Respiratory eaaeer SMR's wet* aa .follow*. turfing with the leweit category. 77.78.28.280. and 12*. Not* of tha othtf eauaet af daath were in axeaai for workera in the 1 lewtat categories. Concsrning their failure to dott axcan raipvatory cancer mertelity in their toweit categories af expeeure. Weill et il. atated: "Such findinte art not necetaariiy incompatible with i linear reipomr eurv* 'aw dotal becauaa of the relative inaensittvtty of curren'ly uied tpidemiolofic mathoda In detecting iii|h. uiertatt* in rink when compared to background. Thar do indicata. howavar. that any axcaaa rtika at low dafreec of xpotura an imaii" (Ex. it TCI p. 131). Waill at al. aotad that tha relativaly high proportion (IS*) of the cohort who were teat to followup and aaaeaaad aliva through 1(74 ma^hava lad to undaraatimation of raeptratary aaaaar risk. Tha upper kmite of tha 00* confidenea mtarvaia af tha roapintory caacar SMR's for the 2 loweat axpoaure categoric* ranged ham aboat US to ISO. indicating, in OSHA's apleian. that axetaa nik eoald nac ha ndad eat far this* eiiqtna Berry and Newhooaa (Ex. Ptrittl) * atudiid mortality during toei-1870 af a cohort of fneuen mattrtai production warkatt whota axpoauraa wort ' relativaly low. L*vi of sxposure rangsd from tan than t f/ee lo I f/ee after lift, and cumulative exposure! for the'cohort ivurigid Inis than SO f/ee- yrert. Although txcmivi mortiiity from miiothaiiomi wn obiirved. thcra appairad te be little exceii mortality from lung career. Mott of tha mciathtlioma eaiai had baan txpoitd to aibattot lavau axcMdutg S f/cc. Tha cumulatlvi axpoauraa te aibettoi of tha maaathalioma caiaa warn not reported by tha author*. Unexpectedly, thin ctudy observed axeaiaiva maaathalioma mortality but only a non-ngnifleant axeau of lung caacar mortality. A uaabia portion ef tha atudy cohort had a then fellow-ap parted between their initial exposure end the study cut-off dtta. Far example. 22* of the min had follow-up periods of laaa than 20 yaara. Lung eanetr nix may bt axpactad to mcraiia in this cohort aa tha mambars are followed far e longer panod. 2. Summery. A number of epidemiologic studies hove txaaiatd txpoturo-respenae relationships for ssbastos and aibettoe-related diaaasaa. OSHA raeagnaaa that thara era many Inertubia uncartamtiaa aaaociaiad with apidaouelogic itudias of exposureratpenaf. Rarely, if aver, are pereonat lamplaa af asbestos concentrations for exposed workers during tha ratiro . ptnod of expotun availablt. Invostigators typically have developed individual indicts of sxposurti from reconstructed occupational histories, roerat industrial hygiene data, and . assumptions about past working aondiueoa far which xpoeunt were not measured. Another question eoneomi tha factors for canvanion from historical mathoda of maaaunng duet concentrausnx to current mttneds of measuring fiber concentrations. The ratio af millions af Pamelas par cubic foot (mpef) to Abort par eubic eantimetor (f/ee) has bean suggaatad at ranging from lit te 1J. Conversion factors of id for mpef: f/cc in isbottet mining end milling and tri.4 i' asbestos production and Mbeetao camant oparntiona appear reasonable to OSHA. OSKA alia recognises tha statistical veriatioc) associated with aatunation of Standardixtd Mortality Ratios (SMR's). loch statistical variation, at wail at diffaraacs* in aiudy design, statistical power, and length of follow-up. may account for tom* of tha divergent finding* among studio*. Bacausa the preeent OSHA PEL of 2 (/ ec wet effective in 1PT8. there are few. if any. eeeupetional eoherts txposed soialy te 2 f/ee or last who have follow up intervals sufficient for the appearance of disease* related to aibrttet exposure. Al prvtmt. OSHA it not swur* of any tmdtnet suggesting (hat intimity of txpotura will fTect txeeu risk in a manner different from eumu/awva t.tposurt which encompasses both duration of exposure and Intensity of exposure. Most pidainielogic studies hsv* obtarvad '' increasing risk with inertuing cumulativ* axpoaure. Qmuott af txpotura may hast an independent afiect on mesothelioma risk (ta* SacUon V. Quantitative Risk Analysis). A weaker exposed ta th* OSHA PEL of 2 f/ee for to yaara would have a cumulative exposure ef 100 f/ec-yatrs. Hanca. itudias af worktrs esQmaitd to have rveaivtd dost to or less than 100 f/ cc-yan provide avidtnea conetrmag ntk from ixpoiuro to tha OSHA ataadard. even thoagh tha past intanaititt af axpoaure may have exceeded 2 f/ee. OSHA consider* that tha following studiaa have obtarvad inersittd nsk clot* to or baiow 100 f/ee-yaara. Barry at al (Ex. 84420) obtarvad a l* pravalanet of ertpiutions. possible atbestssis. and eorti/wd aasoatoaia at 37.41. and IS f/cc-ysart rsspeeuvtiy among asbtsto* taxala wsrkars. . FinJraataia (Ex. 84-OS4) observed a 10* probability of having certified atbeitaaU among ubosted eamant prodaetioo werkan with cumulative axpoaam of Im than M f/ee-yaar* who had hten obtarvad 22 ytars suic* their initial taposvos. FinkeUttm (Em 84240) aiaa obtarvad oxeaaaiva lung eanetr mortality among workers with average eumuiativo axpeausa* of 44 and Kf/oe-yaar*. Among asbtstes tantilt workers. Oamont at al. (Em 84-038) obtarvad txcotaive monaiity ft.m lung eanetr and noa-maiignaat raapiratary diaaasts at eumuiativo sxpatursi of loot than 1000 f/cc-days and lOBMOiBO f/eedays (equivalent ta laaa than 2.7 and 2J-27.4 f/ee-yaara). Htndarioa and Eatarlina (Em 4444*1 obtarvad about a 2-fold increase in hmg eanetr mortality among rotirad aibattot production workers receiving an avarage eumalativo axpoaura of It mpef-ytar* (euwvalsat to 17 f/cc-yttr* using i conversion factor of 1:1-4). At tolativtly low cumuletiva sxpaiuras. the following itudias did not obtarvo txetts lung eanetr risk or obtarvad only a small ineraaa* tat lung eanear risk. Botry and Newhousa (Ex. la-0211 obtarvad Utila txeass lung cancar mortality among friction malarial production worker* what* cumulative axpoauraa avamgad last ihtn SO f/eeyears. Meoothaliomt eases wsrs obsarvtd by Barry and Ntwhotut: DUP 0907234 J vC 7 ' 3 DU 028335 fcdctat Register / Vui. tfl. so. 215 f rrtuny. Viwvr. vhtr eumuUtive exposures were net raeorted. Well] ft IL (E*. 04- Erincuca and Oakland fKanurck ft ail. Dnn and Simpion emeiudej m iisit while other itudit* did nut obstrvy t 1971 pupar Xancer af A* iunp ind 2061 did not find meraased mortality Xriotionibip bttwaea tibuioi m -- muathalioma* do not account for ill :he from any cinx of dtn below tci drinking water and eanctr incidenct. txceae of daathx a |ntfium txcatt of mpcf-yeart (equivalent to 141 f/eeytr* (Harrington et el.. Meigs tt ti. Levy cl ethar uncar* remain. . . md met of using * conversion ftmtor of in a al.| (Kent Et. *4-1 19). OSHA n awert thau appear to be m tht lattreimexiinai cohort of asbestoa cement worker*. thtt ecological aiudiee generally heve tract" (Ex 44-041. p. 233). In thtir 1977 Rubtno ft f1. (Ex M-M6) observed only certain iimnetiona for deiermimni the paper. Dmei and Simpton reported a t slight txetss of land eanctr mortality tiTtctt of lon|-trm tnvtronmtsiai dtdino in both aabuiona and fond large exctxi of mortality from exposure to spaafie eubetunue. taitrolnttatinai uncar a* motor eeuna othtr eausas. such m son-malignant ineiudini confounding variable* tush aa of mortality among the eurvivort mpintory diaeaial despite high mt|rttien into and from communities followed from 1947-1971 xposure laveit. Oota were not enalyted and multtpla txpeturtt to other by Rubins ft ti in <uch i way a to ureinetanaand toxicchamicsts.fof SalihsfT. Hammond, end Saidman atudiad a cohort of S7J0Q U4. and permit rstimanon of rnk from low txamola. increased uncer mortality in a Canadiaa huuitUon worker* (Ex. 14- cumulative exposure*. McDonald ft (1. (Ex- M-06S) obftrvtd particular community may ruolt from _ occupational exposure* fatnar th*n tram 060). Companion af mutators mortality during 1967-1974 wa* made to aga and Uttlc or no excel* lung eaactr mortolity calendar pariod-ipeofle mortality rate* amoni asbastes trunert ind mllltr* ambient air.Secauu Hudu* at-- of US while train. Tha large sue ef receiving lew cumulative exposure*, beau mortality from pneumoconiosis occupationilcoharta da not.havo aa. thla enbeet ruultad in vary high many limitations u ecological atudiaa. . ttatitUul power to dataet ineraatad wit oburvod in theHow exposure (roup, howavar. Workirt reeaiving iaaa occupotional atudiaa have tha potential to'EtSdre letenainauv* concerning_ atonahty fram *pafie uuatt. Therefera. OSHA consider* thet this than to mpef-yesre by aft 45 had an urphafcnic riak to humanx depending study urrtct much weight with regard SMft o/2Mfor pneumoconiosis (30 oneiso of the cohort length of _ to tha nutation of asbestos-ir.ductd mpef.ycare equan *0 f/ee-yaaro using a conversion factor of 14). Aa ia commonly oburvod amoni epidamioiogie atudiaa of ttiologic afants for diaaaaa. tharo art aoma ineonaiatanctM la tba finding* of -- different itudift of worker* acnmulfUnt ralatlvtly low txpoaum' Siabiticai variation, difference* fa tfta ' tfxe diatnbeboa of airboraa 15ban. hapractaion of txpoaurt tstimatax and competition among diiftiom caaau of death might explain aoma of tht lnconaiatanciu. Nocethalfex OSKA canatdan that many well-conducted atudiu oburvod tubatantuliy tneraaud riak af datth from hint uncar and nonralifnant respiratory dliaau amoni workers racaivins cumulativa exposures permitted by tht .jrrtnt OSHA standard. OSHA eoneludat that thaaa ttudy raaulti provtda tvidanw of frova d*B|tr from low etunulatlvo txpesurss to asbestox C Cere/noftnfeity ofAtbotto* foe Sit** Other Tlwa tht Lun$ and Stttothohum oFurvation of tho enhort. tad othtr porGnent tutors'. Thirafora. because* well-conducted epidemiologic (tudiu of oabaatoo worktn an avoilabit and became inhalatian rtthar than ingestion ia tha pnmary route of workplace exposure. OSHA haa baaed lu conciuaiou on tht potential enmnogsntaty of aabettat tor ntu other than tht lung and aiesothaUum on aptdimtaloftc atudiu af atbutaa worker*. 2. Ephtomiotofy Studio*. Chat* and Simpion atudiad tha mortality of Salfait iMwatora amployad durtni 1M0. mottly in ahipyttda (ln. 1*77} (ExhlblU 64- . Ml and W-oui. Vital atatua wu aburvad dunn| tha period 1MMI7I. Cxena mortality waa abaarvad from aibastuia. luit" unear. maiothaliomx and iwtratataiunai uncars (atomach. (aiunum. paoertax colon and riciam). Eimaa and (.otpaon atatad that "both ia ratpiratary and ia laetroiateatiBal caacm tbau is tha dlificuity at diffarantiatina batwaen muothalial tad pithcUal tuns on * (Ex p. ITS). malignanues. The invasngators sought suppiimemal cllntuL aurgtul. and aatapay information in ordar to datarmutt tha txtant of autdatsiflution of cancan. laaad oa death cartifiuta information afonx aitmfiunt ixetsi mortality was observed Cram lung uaur (Sf>lR408), mesothelioma (104 dtsths). uophagtti uacar(SMXwl53i. sumach causer (SMlwUS). eofoD'iactal cancer (SMRwitt). laiyngtal uncar (SMRwItU pbaryngoal and bucul uvtty uncar (SMR 1S8I. kidney uncar (SMR31. all ether cancers (SMR-lPU and nonHnfteuous mapiratary diaaaua (SMXwiKl. Ineluding 71 daatha from iibcstot.t. With tha axoapuon of dtothe listed es "ail other uacen". r-slaieifieation of daatha bated on supplemental chnieaL autopay. and turtiul data rtsulted in slightly higher SMR's for tho uuaas ef death listed above. OSHA baliara* that SalikelT et al.'s radassinoiios of cautaa of dcitn is t. imnduetioo. A aambar of atsdfss of Of tht total US ftttha in (hit cohart atbottu work*n kava abaarvad eithor autopay infarmatioa ar clinical juaUflabla bautme misdiagnosis ef maoothalioaa and asbaitosn can oceur excesses of uncar at titti ether than information with btopaiu and/or da to thoaa canditiona' resemblance to tha ianj and metcdheUua. Thau aim Include colon and return. taaphegux stomach. larynx pharynx bueeal uvtty. fcidaeyx and evertaa-Baaad aa thtu ttadiax OSHA haa aondoda4 that Kiirmataatiaal maifoeenote ippatr to va bean pcodtioid by aabutat inhaled la tbs woritptocts. apwEceuaiaty^MuSu^va iwysst.iit.nd laditfrapha aupplatnantad tha duth . oertificatn for ail but a dttihv By 1M13 daatht had baao coded aa faatroiniMtinal cancan on death cartificatax U ef which oerutnuad to be dtaitfitd at tutiointnttnal cancan after auppiamantal information had bean obtained. Um tha axsacted vaiua of S.lt daatha for all neaaupiratnry cancer* that were rtparsed by Eimaa meet common disetset. Furthermore, it ia pacaibla that mataataiea from primary lung cancers could be misdiagnosed at primary uncars of other sues, and \ ice- vanx OnodUodvanuta of raelaiiifiution of daatha. however, is (hat tha anient of miaelassinuuan m ih* aoflipartaan population of US. whu* mofos romotaa unknown. Nonetheless. OSHA beiievs* that, for this parncuUr iCTlffigdi oynpo.i)on'pfjijbato m . JHSung waterjQaxtudyjutttata^ thauahaaMa ia .drinkmg wnt.ar Inertmad cancer incidence in San and Simppox OSHA ulealaiad that tha laitrointrtunal cancer exuaa wa* ttattaiicaily aintfiunt at lha Q-OS lava! (orwHailad Ponton tut). cohort, tha odvanwge of reel.isufie^on la farm* of improving the certainty about tha causes of death outwetv"* ti1* disadvantage. DUP 0907235 DU 028336 SllTg Federal Ragiitcr / Vnl. 41 N'p, / F'd:iy. November 4. \%tj / pu|c, 3nd Res'.ilnf.nr* In the category liaud "*U othar uemg a ant-taded Peiaaon test). workan). McConald and MeDon.-ild cancan." 232 death* wen obtervtd Nieholion. Saiikoff. Saidman. and (iibrttea gai matk workan). Peto et <!. compand to 1311 Jauihi axpeeltd. The Hammond lEx. *4-2311 alio itudiod a (ubaato* iixttla workan). Thomat at al. exceii in thin uttgcry w*t svontfy due cohort of U.S. aibaatoa factory womra (libaitot cemim worktnl. Roiiiur and to mertaiad monilily from pancreatic tndobwrvtd a ataiiaticxlly non* Cotai (thipyard worktnl. and jontt tt: cancer (SMR *2(1). lit aland biliary tigmfieant 13-fold axeaaa of al. (aabeitu |i> matk workan) (Ex. *4- inet exnccr (SMR2Mrprostate iiatraintaaiuial eanetr. Nawhouaa rnd 23|. eanear (SMR137). and brain ea.-iear any (Ex. *4-3301 obaarvad a When non-giaireinttirlnal cancan at (SMR 1*3! When nciattified (attromteitintl eanetr SMR of 134 in a itat oihtr than tha lung and according to tuepltmtnttl information, cohort of london aabaitoa factory meiothelium an eenatdand. at fain 4 , tha pancreaue unur axeaaa declined workan (60 dtathi abaarved vtnua 44_2 tudita obaarvad axcataaa at that* other greatly tad tha Iivar and biliary tract axpactad) (OSHA eabiiatid that this aitaa: Saiikoff at ai. Shattigara and cans*r excel* disappeared. txcaat wtt iiatlttieaily ai|mficant at Morgan. Puntom at il. and SttU and Saiikoff, Hammond and Seidman the 035 level uting a ona-tatlad Poirien McGill. Othar ttudiaa hav* not obaarved concluded: `Aibeaioi inauUtton taxi). Puntoni at *1. (Ex. 14-244) aludiad axcoaiaa of uncan at othar aitaa. worker* la tha United State* and Canada suffer an extraordinary tha mortality of thipyard warkora axpoaad to aahaatet m Canea. Italy. On* luw* which the Agency had to addrvt* waa how to wtigh tha peeitivt incrattad risk af death of cancar and That* warkara wart aisa axpoaad to apidemioiogie dau veraut tha non* tabaatoti* aaaociatad with rhatr other toxte aubaianeaa. btduding allies, poaitiv* apidamiologie dau. On* tmpleyatat. Thla induda* utertaaet la btnxtne. carben tetrachloride, and eanaidaratioo ia auuttiul power, tha death {ram luit| cancar. pltural patycyelie aromatie hydrocarbon*. ability to dttaet a true nak if auch a nak mesothelioma. ptntanaai mttotkalisma. Compared to tha aga-apaciflc mortality txiau. Tha Chrome Haunt Advitory eanetr of tha atopbxgu*. eaten and rata* of mai* Conotna. the shipyard Panel on Aibaatoa (CH.AP1 unvaried by raetum. eaacar of tha larynx, era- warktrt had itatistieally ngnutcani the US. Conxuir.tr Product Safety pharynx. Kidney, and ptrhapt stomach. inereiaat m mortality from colon eaacar Commtiiioe did aot find a wuiatant Seat* iocnataa war* m*s in eaaear of (raiativa risk 1411. AJi of thattadia* raiattonahip batwaaa hai-ing a higher itvtrai other aitaa. at til. bat data art lilted in thi* paragraph alto obaarvad dagra* af autiauui power and finding inadequate at this tima to pastil eharaetaruation of (hair aigaifieanea. txcetaive mortality from lung caneat. in addition, ether invsttigatoro have xuativ* marulity from thou othar cancan (Ex 44-234). it thauid b* aoud although attention It callao to auch wider tncraata" (Ex. **-090.114). ** Damain and eollfgue* (Ex 44-037] - bljiarrad a itatitUciUy noo-aigmBeant laetata m-dtgutlva eanetr morulity ISMR-m). Whan Dement at *L confined their tnalyaa to white mala* with latency interval* of IS or more yean and examined ixpoiura-mpcnaa raiatranshipa for digestive tyitam cancar. SMR'a increaaad with bicxtsting cumulative exposure. rxnxmg *p to 1*0. BaeauM of the antaU numbers of deaths, non* of tha txeaesu of diguuvt eanetr In any cf tha txpotur* uttgeriai ware ttatitticaiiy Hgnifleant. McDonald and uKeaguss (Ex. S4-0U) obaarvad earn# ineretta* (not ttatitticaiiy tisnificant) in mortality from *toph*t**< and atomaeh cancar and from eelo-reetai cancar among ehryiottit mmtn and miliars * Quebec. Caitromtattjtal cancar Shift** inerttead with heavier eamulauv* txpotur**. Saidman. Saiikoff. and Haaunond (Ex. 14-0(7] ataditd a eshan of UO atnotua Iniulatioa production Workan extpioyad at a New (oniay plant dunwg IMt-lttt. A lUtisticaily aon-ttgaiOaMH oxoaaa af gsstraiauatuui eaarar laaophegaa. atomaeh. and ealan ractm) was obaarvad ISMRwlUJ. Handanoa and Enttrifn* (Ex. *4 till autdtad tha mortality during 1041-1(73 of 134* retired album* factary worker*. Fifty* five death* from digaativa tyatent eanetr waie obacned compared la 30 * death* axpctilud ISMR-1STJI (OSilA t calculated that this exeeai wa* ttatittiealiy ai|mfieiint at thu ODS'lhvai. obaarvad exeattea of digestive aytom canear. Robinson at at (Ex. *4-0112) obaarvad an SMR for digaadvo ayatam unear of 121 (not a auuibeally significant axutt) among ubaato* production workan. Heiafeid at al (fit. 14-140.14-141) obaarvad an SMR af 400 (itatiabeaiiy aignifiunt) far digaaUva ayitaat eanear among tramoluo end aaihephv'hta axpoaad worfcon mining talc. Mancuaa and Coultar (Ex. 04-224) alia abaarved a aitaifleanity alavatad digtatrv* ayaiam cancar SMR among iaiuiauaa warkara. kiakalauta obteraad a ttatuauliy oon-uiumfiunt 2-fold iscraan hi mortality from digaativa ay*tarn tancar among aabttto* camant workan (Ex. *4-140if A eomhar of atudiat htv* not obaarvad axeusiv# guoaintottinal eanear mortality among workan axpoaad to asbestos. Nicholson Saiikoff, Saidman. (Jli*. aad Farmby (Ex. *4-072). who atudtad tha mortality af S44 ehrysatil* mmora and millor* from Qaibec. obaarvad a gaitroimannul cancar SMR af aaiy 10*. WeilL Hugh**, and Wagganspseh (Ex. *4-10*1. who atadiad a eahart af (4*4 ubaata* unant produenaa workan. aiaa did aai obaaera an axeaaa af death* from gaairaintutiaal uneer. Othar laveaifgator* wh* did nbt obsarva an tnenaa* m gatiramusnaal exncsr marulity tnciada larey and Nowheau (frietian auianai* preduction workan). Rubino et ai. (chryaeiiiv mrnonl. Meurman at al. (antbaphylUt* mman). Drown at *1. (talc workan axpoaad la aabaato'*). Want (chryaauta factory (hat tha tardy that hid tha highut autiatiui power by virtu* of atudying 17300 warktrt. aarnaiy that of Saiikaff at *L obaarvad axuiaai of gaacratauatinaL la^ngaal. (ddaay. cad pharyngiaJ aad boeeaJ uvtty eanear. Axothaf aatuidantien la tha roUdonahip batwaaa tha magnitude of axuto lung unur ruk aad axcett gaitratnwauui eaacar riak. CHAP -obaervad that atudiu with high lung cancer axcaito* wan aiaa likely to havt found gaitratnteattnai eanear axnaaat. Beuua* high lung unear Haka would ba axpactad to havt raauitad from raiatrvaiy high rxpotuna. thu obiarvauon luggtiti that liiu-oiniaitutal cancar txetttai art round when txpoaum art gnattr. which IncrvatM the plausibility of then being a true mediation batwtrn album and tutniniaatinai uncer. in aamaury. at Itaat 12 difTtmt occupational eohon* axpoaad to aibaatoa havt barn obaarvad ta have atcasau af atarubty from gastraintrtunal unctr. 7 af which wan luttatieally aignifiunt. OSHA conudan that thn* findingi comiitui* tubsumi.il avtdanu for a* aaaooauon between aabaatu axpaaara and gaairamtunnal uattr hah. The avideaca (or a raUliaeuhip between eebaeioe axpoture and unur at other aitaa it noteworthy yat aot at substantia! at that rtgnniing gatroirutun.ii cancar. CaldamiU (F.x. *4-133) rrnowed tha tvtdcnu for a uum) nUuonahip batwaaa aibaatoa avpoiure and non- DUP 0907236 DU 028337 Fadaril RMiner / Vol. 41 S'o. 215 / Friday. November 4. 1983 f Rules *nd Regulation* sr.o? pulmonary etnear la I studies of 11 results suggest that additional sensitive epidcmiolngic studies havt otorrved occupational cohorts fallowed for ( ammut expenmama are needed* (Ex. tacosse* of eanctr at suss oihtr uun leaxi 20 yeirs unco initial aapcaur*. He 14-200. p. 1U). tha ntpiritory tract, matoiheimm. and eoneludtd Uiat th data "cast doubt on Bolton. Davis, and Lamb (Ea. 14-214) gastrointeattnii tract A number of outer whaihar thtro ia site-apeefieify of admimstarad amostte. eroetdoliic. and studies hv* nor observed increases .n aibestcs-relatod cadpar* nd that "l chryeoula in diet aupplamtma to Wutar mortality from cancan at sues other tystemie carcinogenic rol* it more likely rata for portedi of up to 25 months. then the lung end metotheiium. 1) is [for oibottool" (Ex. U-n3. pp. J4VJ47). Malignant turnon, including Cl turnon, poaaibl* for phyetetans to misdidgnns* L Toxicology SiuJi--.(* number of wan not incrtaitd in the asbestos- poritooeol cwootholietna a* Imieflloev iiiidiatbxvy'botB conducted txpoiad ammais compared to tho lastrointoatinai ar other cancers: to deterntfle the carcinogenicity (_ controla: however, chrysoUle-treatad However, the excess of gastrointestinal tested asbestos. Inhaled asbestos U, rau had a atetiatieally iignificani exceaa cancer petsiited even after Elm** end ttpaghit* enter the di|enve trut vlutn of benign turnon. Tho excess of benign Simpson end SellkefT *t el. ndauified asheptc* fiber* eaugitt m {fit mueou*_ (amors in chrytatile-trtattd rets ws eauao* of death aaing supplemental H5j| of the' lung srvbreught.up tojpj. jUtutasdxu'tllowed. Alio, fiben ltrgely due te tn excess of mtaontcrie autopsy, surgical- end clinical hemangioma*. lolton at tL thsoght that infermetien. OSHA believe* that the esu|ht m the note.titey travel down to thr obssrved exeess of bonign turnon in rvauita of these nelassifieation* ^J'g phiyynx [Kan*. Ex. IWME Iveni'et ysotile-trcated ametola wee nos tL (Ex. !4-23fl) conducted an inhalation likely te bo duo to eaboatoo because eonstitut* additional svulencs for n uaoddtioo bttwven asbestos svpoure study la rata of rtdia-labelled they did net ebaerve asbestos ftban in and dovoiepmoM of gaatrotmastinal eruddolita. JJ* f*dio-l*b*li*d__ , tha mesemtnc lymphatic daaeaa of tho cancer. crumdoliit traveled to the larynx . ammeis. OSHA regard* tho mnnerous esophagus. and iistroiateitmei tract immediately after expotura. and Jvaa largely excreted la the toaa witbio the 10 daya following inhalation. The National Texiaulogy Program (VTTThat adminutervdehrysonl*. . amo*it*7Er*meiita. and cmedolitt in . Joed (1% of diet) to laboratory animate.^ ucreated incidences of turnon ham not Won reported in any of the NT? Jiudiae (Exhibits MS. H-IH, 14-117. *4-22*). ' In some-of the studies. relatively abort Chora worn administered. The aideste* . dote af 1% in diet u aot the 'maximally tolerated dace (MTD). unlike meet earenofineeit biaauays. Ward. Frank. Weak. Davor, tod Tarone (Ex. It MO) --iriw** the effect Choral txpoeun toamoaite or ebryeouie sniaitrsiataannal (Cl) caretnoitneaia Among Fsaa rata who hod boon iniecud with aaoxymethana. AMxyoathkno it e well-eecofnixad intestinal camatgta for laboratory animal*. Rett tveraalao imposed te tmoatte alone and axoxymethane alone. The exposure period waa 10 tseeia and the rata ware ofaaervtd for M weeks or more (aoma rata did not survive aa leaf as M weeks). Aiihaeth ameeite and cbnrsatUe exB^ejira.d^jiotsiMfSeanlijr laereete the incidence efcTclacar among rats, Oonham. lerg. WtH and Uiainfer (Ex. 14-222) fed FS44 rata a dial consisting of >0* thrysenia. A total of 1M abostes.fed rata and 2U eontrei rate warn studied. Regarding that! findings. Oonham at u. stated: "Although the riakdifferancet for dtveisptneat af colon tumor* (pacifically la aat atatiiticaUy significant at the it (aval wa faal than is suggestive evidence that ingested aabes'rs may have soate rale at colon ccrctnotcnesii . .* (Ex. 14-271 P.1M0). Smith. Hubert SobtL Rater*, tad Dotrfler (Ex. M-ltt) adnnieterad aotosite tsbestoa in drinking water to Syrian hameten af tho Laid.VC ants for periods ranting ip to 22 months. There waa some clustering af malignaoi turnon, including a peritoneal mesothelioma, e pulmonary eiretnem*. and 2 squamae# ceil carcinomas of the fomtomach. in the hameten exposed to emor't fa of ISO animals). Non* of the control tnimcla developed these types of malignant tufoon. Smith *t *L duf not consider the duatenag of malignant tumors in amoeita-exposed ammais to bo refated to th* ingattioo if aaoeUt bacaKsa-thOM type* of turnon kava been observed is control Syrian bamatan of tho Uk LVC strata by atkar ptdomwlogic studio* indicating inotised nsk from gasvointtauoal ceacar as outweighing non-peaitiv* epidemiologic atudiaa aad non-posmv* end egurvooni finding* m animal* iaccdting ashattee. Dose-response rtUlionehtp* for gastrointestinal eanetr are chareeterisad las* well than (or respiratory system eencars. * Non*theless. OSHA candude* that gaitromtssttnai naUgnanees shotdd be included is quantnadva analytes of axoasa oanaar risk fram aibestas axpaaura bocausa such oncan kava nuda lubftaatiai eontribouona to the tneaasad maruUty af many cohorts af athaatoa wariurt. Otharwtsa. sxecss cancer risk frurx asbestos exposure weeid be uadarttatad. Tha axcatsat of malignaneies at sites othar than tha iuttg. masothalium. and (aatreiatHUiai tract abserved by SaiifcaiT at *L art paroeulariy noteworthy because of tha large sut of SaUkoff at al a cohort. Tha targe ns* of their oohort resulted in a high degree of statistical pawar and a kigb dagrs* of liability far the abserved SMR's OSHA considart that aibaataa might induce cancer at alum othar than tha lung, masoihciiuni. and gastrointastinal truer rrenaloaymethanelaiaoiaaeJaa alt. rataftcrivint aowaita ajuaa had an _ unusually high jaetdeeirepT*.) af salary *5fdnom aeatparod la thalaeidanea imwy hsetarisal control P344 raft ~" -HUOalxmed la the team laboratory.' - War! at aleeamaatad enthuse fiedmes: "The teeeli* af ihexe txpurimaets aumteet that and asbestos irrtttigatere. B8UA cafistdan that jNart it samrt s vtdpnca that oral rrtgestionTST Kbsstdl S eardhofShie to liboratory animale: hasrtvar. thia o\faPCtJ*"ratnr ihcottststent, T^`ll71i;**li**,';T7lv " ltl` Paa-paaitiytluSkaoie* t* aosnewhet Sauted by the IpayJstM andPtarCSll^l that wart admuuaurad to the animals. bated on the studies finding eanetr axceeaea at these ether utea. eepeeislh the study of Solikoff ot el. OSHA wilt not attempt to guanttfy tho excess nss at the** ether sue* in relation to exposure. OSHA vtours the evidence for tbastoe inducing gasiromiestinal irset cancer as airottger and more consistent than the evidence for ssbesios inducing exuueuru t--y kxv cauoml ja mceeased a. Summary, in summery, st lean 12 ooncsr at those other sites. mcdencc ef labiaim*! inwnrs m xuJa tpidcmioloctc studies have sbsetved DL Cffrctt of Cixorvtir $rwi my KW mis .^Although imriindimadid ool conclusively iknuiaatu'c thc.cn* . caacuwtitetic or carnmun-ftic effect of aaiictiut fur the micstintii met. our incroused mortuiity from |xstruintrtin.'ii eeoeer* among women \pa*rd to sshesto*. 1 of which ware idiitiieullv sietufiexoL Also. *t loaat 4 1. Intnaluetioo. A multiplinuiiw uffi-i.i of uabrstoe exposure end cifuri-iic smoking with regurd to producing DUP 0907237 j)U 028338 51108 Federal Renter / Vul. <, y0, y; / FhJpv. November 4. Wj / Rjln and R.-vuiji" incre^ied Iun eanear nk was ihown In 1004 paptr by Seiikoff. Chur*, and Hammond (Ex. 2-5| Subaeaucmiy. other tudie* of occupational eahorti confirmed thit finding (Sclikoff. Sattlman. and Hammoni Ex. 84-100; Hammond. Solikolt ancfeeidman. Ex. 84-047). Cohan at at. (E* M-COi | ob*rv*d poorer particle clearance tram the tungi of imokera than from the Iunit of npR'taokin Thia finding nay help to axpiirn lha higher lung cancer risk of making aibaitoa weriart. lo addition, amoking aabeitaa workart kava kata rtported to be at higher mic of esbeateeia and chaat X-ray ebnomsliue*. inciudinf piaura) plaquee Hammond at *1. Ex. 14-047: Wtiaa. Ex. +-0I7; Wtiaa. Ltvtn and Coodman. Ex. 84-OH)Jhtra mmjtytdanu Jeejn aaaodauon b.ttwettmurett* atnpfciM `j'nd aithar eitaothaliome ruk or IlitriatMtinil caasar riak (Hammond et al. Ex. 84-047). Z Katpmury Cancer. Hammond at i. (Ex. 84-047] collected tanking bistort** 8am tm at the 12081 Insulation worker* with a follow-up period ef a or men year* ataca initial txpoaun who had btan studied by _ SelikofT and colleague*. Tht mortality experience of thate worker* wu obterved dugrag 1M7-1P7I. Of the 1220 .worker* who ttuwend the queidofliiafn on imokinf habit* la late 1M 8*41 wart either eurrant or peat cijaratta maker*. 488 had a history of pipe or ei|ar imokin*. end Ml bad navar atnoktd reguleriy. Tha companion population -i drawn tram the American Cancer Society'* long-form praipecthre apidcmteio|ie (tudy conducted by volunteer*. and confined of 73.781 white men who had no more than a high tchool tducition. were not farmttn. were alive ** of [truury 1. 1987. and had a history at actupotional exposure to duiu fume*, vapor*. gs***. chemical*, or radiation. The malor advantaie at thi* campartaon populatioa waa the availability of ape* specific mortality rata* by making iatu*. Al**. meo with the above dmertbed education and occupational histone* likely wettld resemble the initiation worker* more than the general VS while atala papulano*. Age-steudardued hmg cancer mortality ram far control* tad far ttliettao wtrkar* are give* in Titbit S. A* ihown to Table t. een-amoktng talmtto* workers bod a mortality rate from lung eanear ihel wai 8 um* hither jhan lh.il of rton-tmohiiig contruit. Thu lurg cancer morml.ty of imokme iihciioi worker* wai alto 5 limi higher than the control* with ehiatcry of ejarette smoxmg Thy*, for both imuking and non-imokmg uuanoj werkur*. the relative nix of deutn from lung eanecr wj .Ixjgt j.f0,g. Hcnci, me roljtmnfhip between eittreiie imuxire *nd asbestos exocture can ben a* desertbed < mult,pi,eat,v, m noiur, ' Twit t *e.Jt4H4ir#UH iat| Ctnctr teatn latta ly So*ain iutus me OctuottiaMl tniteey *f Uatttai (tetivrt krev# Ueetart U UMtaif mt eery if Ctyartui Sasttnef beau late* Hermit/ Siffirenc* Homut/ *<tte Centre it Asm* cat nvi 0 Tee bb n.i 0.0 be ' U.4 * 47.1 I.U0 l.il Cmiroit bn Tbt I22.S llt.J I0.M AIMSUt untft TU Tl* <01.8 a.n HUu aor i00.000 uan-ytar* itaMiriUH far gaiatM *>tt< -taoen af tao aan-y*r* af at) in* ataeate* aeraar* taatee to aorta certtftttt* tafaruattani frm mrasns et *>., Ct. 14 047 Regardui| that* data, tht N10SH/ OSHA Asbestos Work Croup fluid: -The aamWaad affect af making aa* utww **poawa appear* t* be more then iafl* sedition. If the aeahmad tfTcct ware additive, ana - mid expect death ram af 1M7 per 100.000 mea-yeei* aman* aiOaitai warkin whe Meked. Thi* raw wu danvad bum the turnthe baseim* rat* |1U) plat tht axeaea avar that MaHna 4aa ra aahcataa (**.^11Jw47.ll flat dw tuna due is MMfckg (lttMU-mJ). Tha data wea ntbat (a untfy mhtpiluiivt sweat ' wa* shewn that amakiag alena mrrsand the death rata about 11 Haw* and aabettt* alee* bend it I Mate. Tharaftr*. far a estiva model, the eienaUiy ran* far these expesed a bath ubeatea and imakaig voald bt SI (I bam 11) twws patter thaa thcee whe wart axp*ad aaitiwr w athearae cor W makiag The menaliiy rttra for lhuaa expaeod t* ttbaaiaa and t* etfaivtie* wet dually Ulf (lx. SM9L p. CU SelikofT. Stidmaa. and Hammond txamined the effacu at eigerattd amekini and aabettot axpotura among Ml amotitc pfcduodon werkers. S87 of whom had amoking hittortb* (Ex. 84IPOf. Am in Hammaad at al.'a atudy. eoetparteco wu made to age and eautt. tpaciflc mortality ratal wuhin aaeh imoking iiatu* category af the American Ciincor Society (ACS) cohort. Non. amoking tmoaita woraara had a greater than l-fold inema* in iuag eanear nix compared ts nsn-amokxrt ui tht ACS cohort, while amoking amosit* worktra had rn almost 8>fold lner*ie compared to ibtir amoking ACS catmtarpantDa**d on th* txeeti lung unear mk in non-iraakcn. Sellkef! et tl. atattd that aabaato* exposure ties* prodacad an increased risk of lung uneer. although tit* Incneio tmeng ncn-mckir* we* limited In terms at total number* of additional deaths. For dgtrettt smoking asbestos worktra. Selikoft et at. dawribtd th* tncreaaad number* of lung cancer d**ih* at "devaiuting." StlikofT *4 al. ebdtrvtd ao ineeaaad n*k of duath Iroa mnsotheltem*. DUP 0907238 J DU 028339 f full -< M..H .u* s*h<njtriicAt!rul cunccr and uebesioaie mun* Ifr.uk.ny umo*ite worker* u>"'Prvvi lu non-smoking jmotite orken. 3 l.ung Dittat* and Chett X-ray t "fumiahuet. Hommond i *1. rejarred ill.11 olderoil* workers who smoked un* nr mori pack* okigarette* ptr day r..vj on aahcito* marWlity rate 24 tuna* hither than that of ixbeatos worker* who had nvr smoked regularly (Ex. ta_04T|. Hammond tt L alto reported (hat gs-imokan who wtrt asbestos worker* had substantially lower deeth rate* than aabaatot warden who had not quit smoking. Wtiai (Ex. M-4fT] conducted a dtett X-ray and queanoanaire aurvay of 100 eabeats* tevule *orban. Woia* rtported that smoking worken had e 40* prevalence of pulmonary nbroait and oon-smoking workart had a 14'i prevalerte* of pulmanary Gbrottt. A (radiant in riak of fibreii* waa observed for both increasing aq* and mertaatoq durauoa of expasura. The age diaiributiOB* af the amokan and am* smokers wart similar. aa wart tha madian duration* of aapaaart to aaboatoa. Wtiai condudad that both aboatot axpoaura tod ei|irotto -- smoking wan aaaociatad with pulmonary fibroai* and that smoking otboaiawwotkom had a higher prtvaioaet of ffbrtaia ftiativt to ao smoking asbestos worker*. Waits did no( indicate whether the difference in pulmonary fibrosis prevalence between tmoker* end non* tmoken wit atauatieaUy significant OSHA tasted ibe eimifleance of the dlfTannco m prevalence of pnlmontiy Rbroeit batween amokan and non* tmoktra uaiag a ehi*toutrtd teat of proportions and did not find a significant differtnet (p gntitr than O.Jk In lttl. Weiaa. levin, and Coodaan (Ex. 00400) repenad the raaultt af e aurvty of 4S men egad 40 or mere whe bid worked ter mort yearn in an atotato* manufacturing piaauTha prevalence of pleu/ai pUqas* was grraur m ctgarera amokarm however, than waa Mmc cqpftonding of this ralotiontbip by caMotivo asbwsta* xpaaura. which aloe aaamad Mi Influence the prevalence af ptoml piaquoo. Weiaa at at aiatod: -CwahniMM am lawward bv the eeudl .Mwiwe ml --tern m dot awwtearum. A l4r*c-<nif lu ik* Aursuon u* ru ih<* Ai^n .iHio Hum*** tmuhiftl t ictirumo bhiii rvtduifr * ratu.h Urs**r rv4fvf! effort. pr*fcf*(iit in escort tgur irjk. |4v<V4 P 4a*1 X*ruv ucflvumnc* of Ouimun.irv fiUruitt nor euniniuitnd to tiliroiu rnuitmy from aibcMiw i-ipotur*. In aummurv. there ti some evidi-nc* that imuking eibettoi workers hate < Peeri* (tv *-0-4*91 urvevcd 1.11 hi*hcr rt.k of mortality from nhciiqin. nibtttof-expoacti shiev.ifti wurken to >-il * higher prevuiene* uf ditcrmtnr me nilauve contribution of ertptuiions. lung function dtcrtmrCti aibattoi exposure and smoking to lung md imail radiological opaemei. Thu function decrcmcntt tod enuaa X-ray evidence t* inconduitkt. sbnormalitics. Prarle found that both cigaratta imoking and aabaatot (apoiure reduced FEVt (forced txpiritory volume in 1 sacami) end FVC (farced vital eepaatv). with combined exposure having a "cumulative or poaiibly iyntrgime effect ' IEx. *4-071. p. 391. Ptsrit eito reported that both imoking and atbtatoi axpoaura produced pleural end inttntiiiel abnormeiitiae end that imoking appeared to bo the primary factor In sirway* obatruetion and dtfTuaion impairment. Berry. Gilson. Helm**. Lewinaehn. and hooch (Ex. 14*030) iiudud 171 mao 4. A/rrtbvtmy trvhablt itiohytr-t in Luny CuneerAMWif Individual Atbetiei H'orkart- Enterlme \Ex. 14- 120) aniltTcd the probabiluv thei anv tingle mm of lung cancer in e ctrton with known evpmur* to eabeitui could be attributed to the aibeatot exposure Hit paper rmpfttined Met it cannot be stated with canainty that e lung cancer in an individual worker wet due to aabeiiei tapoturm mthar. itatamamt eon only bo made eonearning pnnliaiilititt of cauaa and effect. He converted obaen-td retativt nskt into arabobtUtiei using tba following formula: tmpioyed at aa aabaitot toxtilo mill a* of |une 30.190*. Smoking hiatonit wort avoUobio for 27* man. Mon were classified a having sever amoked. *i W* - w l--*-- w*w tx-imokr**. or .i current ftnoken (light, medium, or neavy Qgaralte eanaumptien). The mean euaulotivo ffiitm tm^'i - WMV expoaum (nbam/cubic canumatar* yean) wtra iunder among the itiohtsg atatut group*. and age ediimunmu wen made to account Cor the younger agta of noo-imokin. Signifieaatly gnaiar Uting SoUkafTei ab'a date on prtiaience* of crepitatiane and amall insulator*, whert e relative mk of about radioiogteef opecitie* were obaerved in 44 waa ob*erv*d for smoking iibtstot heavy amokan and tx*emektra compand to non*imokara and light workart and non*tmoiua| aibestoa worksr* alike. Enttrline estimated a irsoken. Far axampla. 16% of btivy amokan emetoyad after i*S0 had amall ndiolegical op*'ititi compand to 4.1V of aavtr*aaokri amployad after 1PM. Kdburn (Ex. **?! hat reviewed the itadioi of the --'tienshtp betwien eigamta imoking and X*ny tvtdcnct of palmonery fibre*i. Kilbum entiolaed Waiia'a uat of a definition for pulmonary fibre*ia othor than that sf the probability of 7J1 that lung eaneert went attnbuteble to asbestos exposure for both imoking and non-smoking eibeiisa worken (34/44 v 100 is about 075). Ealerliae't paper it important in exploring the extent to whieh nbatiei can be considired the ettslogte agent (or lung uncar In axpeitd worktri. (LO In his 1171 study. at wall aa the Howtvir. ia the eaia af smoking amall number of worker* reported on in eihettot workers, diehotomtting Wfiaa's 1*7* paper end hie ether paper*. cauaausA as either due te smoking or A atudy by Samel et el. which included , dim to aabetto* does cot teem a relatively large number af aubiecta appropriate te 0S11A. because of the aad which did not find an aifact af lector of ayntrgtim between cigarette cigantie imoking on radiologic smoke and aabaatot. Uaing Sclikofl et abfiormalitie* ehsmetmitte of aL't dels, probaliililiae of uuaation aibeitoii* waa cited. Kilbtirn concluded warn estimated by OSHA for each that ejgiiraita smoking neither produced analogic (actor (Sat Tablet end 7). DUP 0907239 :?i s DU 028340 SHIP federal glitter / Val. 48 Vo. 21S / Fridny. November 4. 1003 / Rule* and Reauiaiien* Ttalt 6 caacer MORTALirr r smoking status^ 1 Luna Cancar Rata par IQO.QOO pgr Tear Smoking Atoestas Insulators: 3(2.0 ftenSmking Asbestos Insulators: 0.4 Smoking u.S. Halts: 74.4 Nofl*Smeking u.S. Halts 9.2 i/from Stllkoff tt at., I979*(i. (4.090) Table 7 PERCENT ATTRIIUTA3LE RISK FROM ASIESTOS EXPOSURE AW SUCKING , Lung Cancar Risk Attributaolt To: Background Asooxtos alone Foraula 9.2 . 40.4 9.2- 41.2 ( AttriDutUlt Risk for Asbtstos Workers: Seek t no Nen.Smoklno 2.4B 22.n I.K 77.2* Smoking alone Interaction of Smoking and Aibtstos 74.4 9.2* 44.2 3(2 - 9.2 31.2 - (4.2 244.4 1I.0S 70.11 IOI "TOC While OS1 (As calculation* difTer from Eatcrlina'seaiedaiion* of attnbetabi* nsk by mcMiat the ynergiaei factor, ibt probability astimaies do mi dUfar mdt Aceerdmf to OS)(A s saMattMs. aabaata* npoNn tatrftmtti to 794% Mid 772% of lung eoacar deaths among smoking aaboatoa ararkara and aon-emoking aabaatoa worker* respectively. 1 4. Summary. 09IIA considera that ssbestnt exposure by itself sea cause lung cancer, ssbestutia. mesethefiome. and leetramtestinal nulignamaes. thereby presenting e significant health risk to-espostiti workers and a grave dearer under current exposure conditions. Cigarette smoking by itself css cause lung disease and Mag cancer. Cigarette smoke sad asbestos osposuro sppear to hove e multiplicative relationship for Mutation of lung uncar. MenuUty from csbcstams kes been reported to bo mertued in cigareue>*mnking asbestos workers compurrd to noa-amokmg etbestoe wurkors. althoiigh this evidsnee is taeuneduMv*. Iheurai plaque* and ihe radiologic abnormalities eherecterutic of pulmonary fibroin tuvi sue brrn reported to be more prevalent in cigarette-smoking asbestos worker*, this evidsnee ts alio meonciusive. Ex- , smakmg ssbsitos workers have been reported to hove decreised lung cancer nsk reiittvt to smoking asbestos workers. There is no evidence for sny rtleiionihip between cigarette smoking and Induction of mesotheliomas and gastrointestinal malignancies. L Jltlatno Carcinoftnicjty end Toxicity ofDifferent Fibon 1. Introduction. OSKA has reviewed the date concerning the relative carcinogenicity end toxicity of different asbestos fiber types end has decided not to make distinction* in this emergency temporary standard by asbettos fiber type with regard to regulatory previsions designtd to protect workers no the harmful iffaets of asbestos exposure. Mataiy. this is bacausa lung ceacer is tha leading causa af death associated with asbestos exposure end then do not appear to be differentials in lung cancer risk by Cber typo. Seme investigator* end cemauttees htv* suggested that different fiber types af asbestos have differences in their eardaegenic patency, mduding Enteriint cad Henderson (Ex. M-122L McDonald and McDonald (Ex. 1^1ML WaiU at aL (Ex. PMSMl. Achason and Cardnar (Exa. 4+-013 and M*Z3L Muir (Ex. B4*M0L and ths Advisory Committee ax Asbestos (Ex. SA-nS1. These scientists genersliy believe that eroddolile end samite era more cireinottnic than chryiotiie end enthophyilite. Bated on these sacniitu' re"unmendations. both the United Kiagdom and tha provutc* of Ontario Canada hava promulgated tha following itondnrds for asbestos: W fiber* per cubic centimeter (04 f/cc) for ereeidelite 04 fiber* per eubte centimeter (04 f/cc) fbroaosite 1 fiber per cubic centimeter (1 Vsc) for chiysotiio sad all other forme of x eiboitot Recently, iho United Kingdom ha* announced reduction* in the limits for chryaotilo and ament*, it is important to not* that tha question of differentials in potency by fiber typ* primarily eonc.rnt reduction af ataaolhvliomas. not ibestoois and lung cancer for mesothelioma. Achcson and Coroner m 107$ described "t powerful eusu. ` that emedoliM ho* been more dangerous thun chrysolite end nihophytlii*' (F.x. **-116. p. 1U wharuos they characterised tvidrncr fur DUP 0907240 j 30 7 * DU 028341 fiber typ diiTrirniirli in nak from lung eancar and aabastotit it "ineoneloirva" and 'slight" rtspucuvtly (Ex. U-Zll p. 111. In 1983. Aehaaon and Cerdnor stated: "Ptriiantai mesothelioma hat aa almost width la j:t or greeter. Evidence for nak from fibera tea* then I j*m in length ia inconclusive. A ottical aitelyila of the rvidanee concerning r.ik differential! by fiber type and f,br diatnaion follow*. exeiutivt relationship tilth exposure to 2. Eptdtmto/oftc Data--Introduction: th* tmphibci** oocidolt* and amosti*' Cammarcial aibeatst fiber type* (Ex. p. i). Contenting lung including air.eaite. chryaotile. end eancar. they noted that although ana crocidolite. have baaa obttrvtd to be study (Watil at al. Ex. It JO*) had found aiasciatad with tltvattd nak* of a higher risk among worker* expoeed ta tibeateai*. lung eancar. tad eroctdalita. no "dear distinction" of risk maaothalioma whether txpoaure* by fiber type could be found when the occurred to a luigit fiber type er to slopes tf uae-mponae eurve* wen vanooa combination* of fiber type* compared. Henee. they eenduded that (N10SH/0S1IA. 1*00. Ex. **-M0|. available evidence did net support the Excess lung cancer nak and aabtatatia sssumption that chryaotile wea a leaa have bean obatrvad in anthophyliita potent lunp eauioen (Ex. VM43. p I,. tabiatoi workerr. fcowever. no earn* of In INS. the Chrome Hazard Advisory mesothelioma have been reported Panel on Asbestos (CHAP) convened by among anthophyliita worker*. the U.S. Cenauaier Product Safety For amoattt. an aaaocietion betwaan Comaiaaioa alao reviewed the evidence for fiber type differentiate In earemogtnie riak (Ex. *4-4111. They cocduded that there were incontinent end Incoadutive findiaie with rejerd to lung cancer differtntiala by fiber type. For pentaneal moaotbolioma. CHAP eenduded that epidemieiefte studio* suggested that due diteeae wet moat eornmae m emoctte worker*, lea* ** seaimoa la croddeliie worker* and rare or non-exiatent la chryeoula worker*. Evidence (dr e fiber type differential la pleural mesothelioma rink waa aet expoaun* and die**** kaa beta observed by the following invaatigeiorm Stidma* *t ti. (Ex. *4-0*71. Aoderaeo et *L (Em *4-017}. end Murphy et ei. (Ex. M-S11). For ehryaoul*. the following investigator* have obtained poaiUvt fladtsge McDonald et ei (Ex. *-*U). McDonald end Fry (Ex. UddtU et aL (Ex. *4-04*), N .ehclean et ti (Ex. W-07J). Rubins et ti (Ex. M-OMi Oemtot et ei (Ex. *4-4171. tad Aeheooa end Cardner (Ex. M-dil). For ernodeiit*. potiov* fiedtag* wero observed by the fallowing tnvegttggtors.- eeaddered by CHAP to be u aubauatial at far peritoneal maaothalioma. Soma h(tlth tcientitt* who behave lone* et L (Em **-U*l. Hobbe et ei (Ex. I4-1U] tad McDonald tad McDonald (Ex. ta>lM(. Meuranan et ei (Ex. *4-1*1| observed an txcew tung that avidinca link* eroddeliia txpoaure to substantial ineroaso in eetothtlieaa nak kava suggested atparet* reulatenr treatment for eoddoliu (Ex ***). OSHA hat been urttd to canaidar rcauinni that worker* cancer risk ameag eathophyiUte (liner* in Finland, in addition, numtnuo studiet have obaervad ubtaiota. lung cancer, aad maaothaliema among work*!* axpetad i mtxad fiber type* (Hughe* aad WetlL Ex. U-13S: Wait! at txpoatd to erecidolite or taboatot at Ex. N>ros [sati it ai. Ex. mixtures containing erocidolito wear lorry ti al. Ex. **430; Elmti aad appropnatt respirators. Irreapecttvo at Simpson. Ex. *4-00. Ptto at ai. It-tOi airborne eoncentrationa of aabeatas and Lncgeat ct ai. Ex. *4-144: Seliksff t ai. lirvapadlv* of eeeipliance with the Ex. SI an. KobiMoa at ai. Ex. Hdgy pemiatiblt txpoaure limit. Furthermore. and Baiialga-Manta end Segarr*. Ex. *- OSHA ha* been urged to contider Oin Alan, aevurnl atudiaa of talc minera requiring that tmployaea pxpeaad ta and miliar*, whar* the tale cenumed eroeiduliit be infanoed of ike potential tremolita and aaihept.yilit*. have greater riaki assooaitd witk crectdofite ebterved axceaaaa af lung eancar and and the teeaone for ft*wring respirator lung diaaaat. and reduction* in uaega whenever meMoUr* expoentei pulmonary function (Kltinfaid at *L Ex. occur. OSHA invitee commixit on tfeit M>140.14-1*1: Brown et ai. Ex. turtle. auggattiux and an other elteixaUve 'Gambia at ai. Ex. *4-m). In addition, epprotchct to aeparate nfulelary ttolita. an asbeitifarm mineral found in treatment af cwddeflte. the aoii and water in twn tnlUgea ra There are alee adentifie notation* Turkey, may be reaponaibit for thott concerning the ftiattanahip between vtlLsgtt high mortality raiaa from fiber dimen*acme and ability to caaaf mesothelioma (Artvinli end Dana. Ex. disease. 09IA brlicvea that aabcato* *44tt. Dari* et eL Ex. *4110J. fiber* IntiRfr than S microanetan (urn) OSHA us not ewere af any euutr tune diacaae xml cancer, provided epnkaiiologtc atudiaa which compare thiit the ratio of fiber lcnn*b to filwr .urorkars exposed to diftereni fiber sixea within the seme irduairtei proeesa. Undoubtedly, this is du* te the scarcity of auch occupational group* unee moat occupational popuisticns have been exposed to a mixture of long and short fiber*. Therefore, moat of tht data on differential nak by fiber in art from ' experimental atudiaa rethar than aptdamioiegic studiea and will be diacuaaed in aectioa (D|(JJ hpanmania! Beta. Evaluating the mlative eardnogfmoty. of tht different tabeatot fiber type* Invelvet eompenaon of rttuita from different epidemiologic ttudiea. OSHA believaa that U ia important to note the potential difficulties of comparing different occupational cohort*. Sitndtrdixed Mortality Ratios (SMR'al art nak muter** that tr* dependent on tb* age iiartbvtioo (ta wall aa other factortl o1 the particular study population. Thia ia becauat the vaiuca used for companion, rtfarred te a* m* expected values, era Strived (ram mortality rate# specific for an. race, tax aad caludar period ia the companaon popuiatten. Cancer risk rite* with mnnui age. to that an older population would bar* higher txpactad value* tor eancar mortality Mi(leading results may be obtained when eoatpertag nak mettuna for cancer amoag study populedeo* with different underlying age distribution*. Aa example at the miaiudiag result* that may be abuiacd in web an taataau ia tsven ia Ex 14-ng. which illustrate* that SMX'a of divert* study populatsou may be the same while the actual istaia nak of mortality may vary graody bocaaa* at autanaeaa m eg* diatrlbutien. Sex end calender period of observation tlxo affect expected valuta, because worn*- xvt tower morteJiiy retet from lung cancer end lung cancer has rtana greatly sine* tht IMO * Length of follow-up io aaothor pivotal variable becauat of tht long lataocy penods neeetsary for doveiopaent of lung rancor tad especially mesothelioma. Epidamtokfic Stodiaa afLunt Cancan. Haacahaliomc. and Absatan* The follnwing studie* examined the question of diffarenuai lung eancar nak by ubettoo fiber type by corapanng the iortaUiy experience* af diffannt eceupationai cohorts: McDonald and McDonald (Ex *4-li4|. Hendtrson ana Eaiarim# (Ex 4-04Si. Waiii at aL (Ex S4-20S). McDonald and Fry (Ex Se-OMl and Acheson at *L (Ex S4-0IS). Sam* o. the** etudic* also addressed tht quatuae af diffartnuai mesathtlioma rtafc by fiber typo. Some additional siudits of workers exposed to t unglt fiber type er* also pertinent to (valuation of nsk by fiber typ*. DUP 0907241 j c: 7 n DU 028342 ~ WnfiiiH&MlSWWIMufidniwwaiiBEiimsmaisri<- ritia^imaciii.tiaraTM indudinj McDonald t ai. (Ex. U-06SI Habbi t al. IEx. *4-112). Wi,n (E*. u_ 0841. Dtmam ti at. (Ex. *4-037). and Consuming Hendtnon and Entariina'a on* or atoro yean af empleymmi end ut flndin**. CSHA not** that tha aabttte* laatt 13 yaan of follow-up had a lung eemani pip* tijeturtt may have bom eanctr SMR that wa* approximate iv Barry and Nawhoure (Ex. 44-021). duiti*r than aafliar nttmataa indicated twtea ta high at that af Qu#b*e sun'cri McDonald and McDonald (Ex. *4-tS4) and that tom* of tha workan thought to with ona or mart year* of amploymant luggtttad that eroeidolit# wt* mart hav* bain axpotad only to ehrytonl* and 11 lent 20 yttn af follow-up. earcmoftnie than ehmedl* baaad on stay hart had indinct rxposan 10 Companion of this* two group* of ' thair companion af thl mortality of croetdol::*. Also, workan tn tha mtneri la problematic bacauaa of Canadian ehryiotila nfc*n and miilan *abitea cimant pioa opart lion potthua! diffaraneaa In agt distribution, with that of Canadian Worker* probably war* axpotad moatly to fiber coneaacraHooa. and langth of manufacturing eroadolita-eentaining chryaotil* (Kang. Ex. 04-1W). Another employment (Kang. Ex. 44-tit). jaa maika. For |aa maak worktn. 13* potanuaJ confounding factor waa that Aehrton. Gardner. Plppard. and and 16* of the ohaarvad death* war* erpoiura lavala w*n uneartaia for tteh Crime (Em 44-913] ttudiad martaiity of from lung canear and maaothalioaa group of worker*. famela workan manufactaflng mostly mpacdvtly. la coosalt. 6S and 0J6S WaliJ. Hugh**, and Waggtnapaek (Ex. ehrytoUiweontaiaing gu uaii ia on* of thf ohaarvad dtatha imang chryioula 14 3M| ttudia* th* menaliiy of tabaato* plant (Plant :| during |39 and ftatia ainan and tmUan wan from ltui| eamant pip* worktn In two plant*, in workan atasufaetunng moatly canear and maaotholioma ntpactively. th* tint plant worktn wan txpatad to eroadolita-conuitung gxi miaxa and On* potantiai problam wo* dial tha both eroeidelit* (Ik af preduet) and aoma chry*otila<aminiet gat maakt m penonnai ncorda of th* eroadolitn chryioula. in tha ienod plant, worker* a aaeond plant is U36 (Plant 2). Plant 2 worktn wtri ineeraplat*. which could w*n axpotad to ehryasUl*. amottta (IS bad a largar axe*** af mortality than mult in biaaaa toward observing of product), and croeidaiit* Plant i. Agee at initial amploymant wart piittr or lauar rtik in this cohort An (infnouamly). vary ainuiar at tha 2 plant*. At Plant 1.7 anpubliahad rtport by Or. Han K. Kanf WtiJl at iL nportad ntpfnury lung canear death* wan obsarvtd (Ex. 04-1361 eomaantad a* followt on lyatam canear SMX't a* follow* for virtue U axpaetad (SMR 143. this eompariton: .workan neaiving etnalattv* ubado* itatftticxlly nenHigniflcant). Ona death (1) Two rnafor potantiai confounding factor*, fiber atxa duthbuboa and fiber txpowi** gnat** than 300 atiliio* particle* par cubic foot-month* (atpef. from pleural matoibaJinma waa obtarvod is a ftmaia worker from Plant ooneantratioa. wan act analynd by tha mootha) during tha flnt 20 yean of t. author*, if th* 1*1 mask plant* had employment: At Plast X IS lung canear death* war* higher flbar ooneantratioa* andVar a higher preportias of Ion* this fiber* thtn th* atina*. a hi|fatr canear rttk would bo , axpaetad in th* plant*. * ` (l) Compatfaas af riak maaiwta inch Na araaidaiita taped** ***-U2 Ixtarouttaat axpaaun ta aaadi u" auo-w Steady anana ta aaortrlallte IMRwHl baarvad venue U axpaetad * (SMR 241. p lata 091). Masothalioma wa* maauoaad on 3 wsmeat death eartifloat**, a af which coded aoetbcUeoa aa tho ssdariytag caaao of a* StasdardUod Martaiity Rada* death. A ftatladcxUy itgwtflnt (SMR') and Proportional* Martaiity Ratio* (PMR'a) aught not bo appropriate batwain tho two oecopatiettal oohorta bocaua* of potantiai diffamea* is ago diatributioci and l*S|th af follow-up parted. Handanon and EataHin* (Ex. 64-041) oampand mortality of retired workan axpotad to diffar*** esbastoi flbar type*. After adtusnng (or diifcronea* in erauiitiva duat txpoaura*. Handanos and Entarliu* reported tha following napiratery lyatam eanctr SMR't Car worker* to an aaboato* factory and workan manufacturing aabaatao cement: 247 for workan raeaivtng OSHA aotat that th* apparent differences in lung canear flak by flbar typo obtemd by Wtill at at an baaed an raiatfvaly small number* of death*. Hone*, atatiadeal variation may be eaaatdarad a potable explanation for th* obaamd difteoseta. It fa not known if th* 73S fallow*** torn may hav* cantnbetad to th.. .a apparent diffaraneaa. WtUL Ziakind Waggtnapaek. and Rnaaitar (Ex. 64*197) auggaatad that ereddaiit* axpoaad workan had poorer pulmonary fuaedan thas workan oapooed to other tern* of aaboato*. They nportad that araoidaUl* workan fncnaa* In avaflas cancer mortality waa ala* obaamd at Plast 2 (12 death* tbaarvad vent 4.4 axpaetad. SMR 27V p laaa than 091). Poiaibly. the dtatha earttflad u dua to avanan canear may ban actually bean mi(clait)d particnial xittothaliomai. Achaaos at *1. caadudad that "tha pattam of marta"ty it eaoaistant with th* raw that matatbaUatn* (and pataibly ovarian eanctr) i* paroeuierty tiaodatad with axpotua is eroddoUt*" (Ex. 64-Olt p.347). Acknoa at L' tady h* 2 dvintaga* nladn ta other itudi** of popaiationa txpoud t* diffinm chrytoule axpoaan* only. 36* for workan receiving amaito axpoauraa only, and 461 for workan receiving combined axpoaun* to chryaotil* and ooadolit*. Aaboato* aemant pip* workan kad a vary high lung canear SMR of 322. Header**n *nd Catorliao ttattd: "Mr* who wotfcad is th* production afarbortro aaioratpiso exhibited a biflbarrtak af raapfratsry caaxar. aa did mas with aoma CtOSddlitt tflfeCVW I^IMI* IfQUH that* two group* overlap. w* aould not bo oertaia that oraddolit* aabarto* wa* mponaible for th* inenaaad flak'* (Ex. 66-OM). ' had asuiltr ustg voixna*. a higher prtvaianca of X-ray changes, lower FEVl'a. and raduead diiiuaing capacity. Wat*. .fTVl nfara to tkt voiam* af ate feeaMy aapmd m an* wcwid. aad dJieuxg aapasnr refer* w dw abOity af asyga* * laavt S* ihrtaH aad aatar Uw pubMaary IIwtIi------ Radocuaaa m ftvi and diflaata* aapaaxy an sdicaav* af auptbad A campariaon between Canadian chiyaotit* ounan ttudiad by McDonald at ai. (Ex. 64-0611 and Aaatraliaa eroctdoliia mlntn ttudiad by Hobb* ut ti (Ex. 34-t321 hat bate mad* by Kang (Ex. *4-13*1. Th* Auatralian minart with ubaato* flbar type*: b*ih th* ig* diatflbutioaa and langth* of follow-up war* abailer far Plant t and Plant 2. Nafthar air ooxomsiiten* nor duration* of *atploymnt wan rtportid for th* 2 plant*, however, lacau** Plant 2 had baan *ptr*flng longer than Plant 1. Plant 2 wrk*rt may kav* had greater median langth af employment. Manual manufacturing proeaita* wan amploytd at Plant V while mechanical praeaut* war* atnplaytd at Plant 1. Parhapi th* manual praaam ltd to hightr duit ixpatur** far th* individual workan it Plant 2. Yat It ia ala* poaaiblo that tha mechanical process at Plant 1 raduead DUP 0907242 DU 028343 Federal Register / Vo(. 48. No. ns / Frtdav, Novemucr 4. '.'jiij KuiC* uuv* the diameter* of lh fiber*. rendertnp them sort hazardous. OSHA eonsidsrs that tltii study previdts auggastive tvidtnet for fiber type differential in mesothelioma nsk; however. this evident* j sot wndiiiijn became of the lack of information m the ttr eonetntrstian* and durations of saploymsaL * Both plant! hid sxcasset of Uni cancer mortality. sllhouph only the Plant 2 treeu wet statistically significant. OSHA calculated that the atatiitieal power to detect a SO* laereeie in lung cancer risk waa only tW at Plant L Clven the lew power to detect increased nsk it Plant l. OSHA believes the statistically eaa-tigruficsnt excess of lung cancer it Plant l should not bo disraesrdsd. Also. Aehtson it sL calculated PS* confidence tntsrvols for tun< cancer senility as 1JV3P7 for Plant 3 and U-91 for Plant 1. In OSHA11 vtaw. thaeo evarlapping coofidenea bitervala for the 3 plsat* Indicate that the observed diuereeeei la hop cancer senility sennet be connected statistically different Heoen. OSHA nmchidet that Achaean at aL's study does sot establish the enfstanee of a difTirentlal In tong cancer risk by flier type tn thaeo 2 ocrupetioeti cohorts. Weiss (Ex. 4-0*bl studied a cohort of prednctlon workers S a paper end Billboard factory. This factory had used only ahsyeetile asbestos. Nn increased sonality fram hint eaneer was obtanrad among iheta workers (4 lung cancer daatha observed venue 442 oxaaetadl. Two men died of tbettosis. OSHA noted limitation* sf Weies'e study that fndude lack of aabaatea exposure data aod vary low statistical power. OSHA ealCL--ted that this study had only 204* power to detset a SC* tacnasa S lunp cancer nek. Hence. OSHA dose not consider Weiee'i study as lebabla evidence ef low cancer nek asonp chryseuie wnrkars. Dement et si (Ex. M-C37) ebeerred a hiph lunp eancar risk amosp shrysoiiie textile workers (U detiha observed versus U.10 expected. SVIRwJISJ. A hipk risk af sonality from nan* saiiptam taspanteey disaaaas. taduding baataets. was also sbssrvsd in this cobon (2* deaths sbtirvsd vsrsas *43 Iipioii SMR*2*4). Oat stritootal maidthalhnmf was coofmvad by sutopsy. Savtral ether death oaniflcates bated "aaaeer af the abdesea.* bat tha authors wore amble to obtafa sddltlansl dau to dattnauie whether them anetkular saasan warn actually stMtneUeeua. Expected* values for nortaiity were derived tram U4. sonality rates. Deoient et iL euueeted thautho hlpher risk ef respiratory < ownelliy in their chrysolite exposed workers employed l- yetrs et pt.nts Au cohort compered to cohorts of cnrytotile B. and C rasptftiory system cancer dinars and millers may have been dut SMR's wen US. 149. and 41 ta different fiber siza distributions. respectively. Amonp mil* workers Using fxpcettd veluts of lunp cancer employed 20 or more years at Plant* A. mortality darfvad from the South B. and C nspirttery system eaneer Carolina county to which the chrysotilt SMR's w*n 1U. 164. and ISO textile piam was located, instead of U.5. respectively. Tha lower respiratory mortality rates, would hsve reduced the eancar risk in mao ut Plant C wf lunp eaneer SMR's far tht cohort unsxpacted. pivtn tha htphar air bocoute lunp eanesr sonality rates concrntrationi in Plant C wars 75* higher tn the county than ut A difftnat pattsm of nspintory the United States as who!*. Dtstnt et lyttaa eancar nsk was epptnnt for aL cssiidared use of the county rites to (satis workers compand to mala be inappropriate beesuse ef the workers: bewevor. ths fsmalt mortality probable contribution of a nearby ram wen not itabit because of tht shipyard it wsii as the study plant to mall numbtr of dsatha. Female workers ths sisvsttd lunp cancer rata* in tha tn Plaits A. 9. and C had rrsptrstory oouaty. Stats (South Carolina) mortality lyttaa caicar SMR's of 234.341. and 52 rates from iunp cancer wire similar ta rstpecuvtiy. theta of tho Unitad States. Dement et el aloe addressed the possibility of confoundmp effects from smoking. Questionnaire* sdmintetertd In 1M4 and :#rt to worksn eotsioyed at tha plant did not indicate that tea study cohort had a bipber pravolanca of smoking compared to the U4. population. OSHA repsrd* Dement et iL's study as stroop evidanea of tha potential for hiph lunp eancar ttak from axposur* to ehrysotile. McDonald and Pry (Ex. M-CM) pufaiiafaad a preliminary report on their study of 2 asbetteo fsctortsi (Plants A sad II when chrysodis wss need txeiiiiively sad 1 factory (Plant C] when ehrytotils. saostt*. and soddolits wan used. Plant A was tha study plant nported oo by Daatant and sellsspues. Plant C had previously bsen studied by Robinson and eolleapuai. Kaspirstery syslar* conetr mortality was la excess at si 1 plans. Expected values for rich plant were derived from the ape. sax. and use-specific tneruiity ratae ti the states in which tha piaatt wan looted. SMR's were McDonald and Fry chanctanxed the diffennoea ia ths distribution of atsothtliema dssths tmoep tht 3 plsnts as "Unking." Plant A had 1 dttth from mtsothalioma (04* of aU dssths) snd Plant 1 had ao doiths from masothelioma. Pint C hod IS dsath* from motethotieasa (IJt* of aU dssths). Possibly, aa even pnatar number of deaths from motothtUeme ocoirmd at Plant C due ta unneopauad eases bring coded u abdominal cancan or other/ utpadfitd eancsrsu Rsbtasoa et si (Ex. M-4PZ1 hod also sbtervod a hiph masstheliosia risk amenp workan at Plant C McDonald and Pry ooneldersd tha probabUity of aiatinp tree usta of mesothelioma et Plants A and I to bo low because of pood eanoar uu tsconsiament in tht ones when theta pionta were located. McDonald and Pry stated that exposure- response nlationships at tha 3 plants might be dariBed eftar the Individual tubjscta ware dtitifitd by exposure level*. OSHA eeiuidert the following points important for tmarprstisp ths findings of calculated beptruung X ystrs after McDonald and Pty. Aithauph McDonald initial employment at tht plans. Air and Fry tmttfrsd by dundan of oonctatretia ia wen biphtst la Plaat C. aaxt ta hiphaat ia Plaat A. and lowest in Plans B. CnUfis far tnelasioo tn tha txposun for thttr iitsr-piant cosspirison of lunp easeur mortality, other important inhabits were not study eohorta wen: (11 Orta month or caotreilad for. lacludinp ep* at tnuut sara af aspieymant by (tnusry t. (Ml. employment fiber concentration, end aid (21 kaviap any Seas! Security * length of feBew*up. Plant C whteh hid Adainittretioa file*. Vital statu* wss the prtttett number ( death* from dtttnunsd u of December Jt. 1177. atsothtUsau. also had tha highest Tbs overall nspintory systtm eaneer txposun level*. Hane*. OSHA SMR waa lit at Plant A. eonfMni the oonaidart that tht differentiais in kiph hoip cancer nak observed et tha saew plaat by Dotntnt tad colleague*. Furthermore. McDonald and Fry noted that their ioduaioa of clerical wetkan and workers with 1-1 otenth* of txposun m tha cohort unlike Osmant *t mesothelioma rtak toteag the 3 plants an tupgiitive. but do not conclusively dtaonauuta increased mesothelioma nsk from cnadolit* nlativ* ta other itbastat fiber types. Of intarset k tn findinp of higher lunp cancer risks at the ai, probably reduced observed - nepueMqr eancar nek. Amonp male ehrysotila pleats (A and SI relative to plant & Again, the variables of fiber Up 0907243 DU 028344 3 l i iV fCO"" / vot, S No. j,5 / Friday. Nocinmr e. Vjgj , Ku,,., nn Krsut.,' eoncrmrstton. ape distribution. end tenpin ol fallow-up naed to b* controlled for wren comparing lung cancer risk of different cohorts. Berry end N*wheat* (Ex. S4--02t) end Nrw house. Berry. snd^kidmor* (Ex. 44- 183) ttuiim the mortally of e cohort of worktn msnufactunap friction mettnuls. Exposure ell to chrysolite exclusively, except denn* 1I2V-1933 end '.J3*-1944 when e strjtii percentage of the workforce wee exposed to crecidelii*. Aebeetoe exposures were low (a the plant; only l* ef the eul* worked eeeumuletod ee much at 100 f/ co-year*. The only cs* of death in eaceaa wee neaotheiicnte. To euteine etiologic feciera for steaotholioaa. a matched caae<entrai study wee conducted for 10 meaethelioote ease*. For each eaae. eoatrola war* leiectod tram the plane Control* were atetched oa year of hire at the factory, can. ape. end duration of employment. Definite cracidolite exposure waa dlacovorad In tha occupational histories for of the 10 miaothebom* caaoa and for J of th* 40 eoatrola. About *03 af the caaoa and IS* of the csntrola hod boon axpooed to level! ef ehryaouie axcoedtni S f/cc When Barry and Newhooee limited tl>pir companion to thote cues and aiatc&ed control* who had beeo txpeeed hi ovar I t/ce of ehryaouie. statistically tigaifieaaTireater aumhar ef ceaaa had an occupational hleteey ef exposure to enelddlt* ae well. Matching the controls for the mesothelioma cases oo year of hire controlled for the important factor af l*R|th ef follow-up. 03HA eonatdor* that both eroeidolite and chrysotilo on implicated in the causation of mesothelioma by this atudy; chrysotilo boeauaa *C\ of the eaita roeesvtd high chrysotilo atpoiurtt ecraparod to 25*1 of tha contra's, and creadoiru baeaaaa *03 of tho cases competed to 7S% of tho eoatrels had been txpoeed to croeideiits. Tho Chronic Heierd Advisory Panel on Aaboatoe (CHAP) compared limp cancer nsk par unit of eumuiuuvo exposure laiao known at Kv tho leap cancer potency factor) omoop tho cohorts spaced to different liber type*. CHAP reported that itudiee ef chrysotilo worker* yielded both low-end kith values of Kv a* wolf ee etadiea ol croctdoliie workers and amoeit* Workers. Hence. CHAT considered that vtdanee for a diffartntul in lunp exnear nsk wua mtietl arid uicanduant (Ex. *4WI. Paifidnuy Studitr: W.icner. Berrv. and Pouley |E\. H-S121 ssamtm-d me aabesiot contantt of titauc tttmpiaa el lunpt of iibeatea textile workers who disc from mesothelioma and other causes. Wegner at sL did not find atthcr higher ehrytoule or higher eroadalito contents is tho lungs of tho meaoihtliama cases compared to tho lunpt of asbestos worktra whs ditd from other causes. McDonald. McDonald, and Pootoy (Ex. M>123| conducted a study ef th* mineral fiber conttnta of luni tliitos for Meutopaied meuothaltoma cases and W autepatad eoatrola. Ceatroit matched for sax and ago wart itlecttd for each moaotholioena taae. All contrail had been diagnosed as having pulmonary tnetaitatet from primary cancer other then lunp eancor. Lunp tiuuo specimens wore examined for mittenl fiber eonlent using an elsctroo miacroscope end X<roy enerpy-dispemve analyzer. Chrytotile. amotita. erocidolit*. tnthephyiiite. an ' tmmeiite were detected in die lunp specimen* ef the cases and centrals. Far amoaite and croadoiit*. about 1 tunes at nitty tnotothoiiome ettrs tt eoatrola had atom thaa t aillfoa fiber* per pram of drtod lung tttauo. FOr anthophyilito. twice as many casta at controls bad man than t million f/gram. For chrysolite sad tramalii*, little difference in fiber connate veto observed between cam and control*. McDonald. McDonald, and Pootey stated: The equal quantities of ehryaatilo fibers h tad in lunp tftau* Cram to*** and controls fail to support any association between this mineral typo of eabeitat a.4 moaotholiel tumors. However, tho lunp chrytotile fibre eootent at death must be interpreted cautiously, at thote fibres probably dteeppeer in the cute** ef time' (Ex. M> tn. p.430).' Thor* era several points to eonetdtr concerninp McDonald it iL a study. Flrat# if tha fibers rctponaibl* (or iodaemp mctotheUuma were also raspcaatblc for inducing cancer* *t etlei ether thaa the lung and mcsoihciium. thee true effect ef a fiber en eeethelieeus genesis could fail to bo daKxted because of the Itiouiaimn that II contra!* had to hnv pulmonary meuttate* Cettrotniettinal careers icmeiimpt metastasis* to th* lune. snd u.me studies have observed #c*e*r| nf gistroiniestinal esneer emene otboties worker*. Second, tine* chrysolite constitute* up lo MM of eommeraally used stbestst end since eebepto* txposur* is ebieuttoux one would expect oaatrals le have chrytotile fiber* In their lunge. Th* widespread exposure to chryeout* could oberara a true relationship between ehrytoule end mesothelioma. McDonald *( *L ruggettad that ehrytoule may be dssrad fatter from tha lunge then other atbceio* fibers, to the! ehrytoule ratennea ui the lung* may not be the best way to esttmtie ehrytoule exposure. Rowlands. Ctbbs. and McOonaid (Ex. *4-17*1 suppesied a tendency for chryaotilo to bo removed from the luag* becauta of tbeir observeuon that th* quantny of traaoliie in the lunpt of Quebec miners and cutlers wee similar to that of duyeotiie. despite tho miner* much raster exposure to ehrytoulo. In general. OSHA believei Uut th* results of autopsy Studies of fiber content ol longs cannot serve at diram meesuns of rtgkdifianaiui* by fiber type. Mvethttiamo Fittdbp; Ae mentioned la th* iatroductien te this section, th* primary beet* for th* hypothesis that eroodolit* is more ctrcmepente than other feme of eabetiorit th* obttrved variation m mesotheU'em* mortaitty among cohort* txpoeod to Olfferent fiber type*. A summery of th* percentage of daatha from meeethellonu among cohorts oxpoood to dilferant fiber typer fallow*. hfeurman tt *L (Ex. *4-258). who oboervad txcttt lunp cancer mortality among anthepbyUit* miner*. did not find any death* from mesothelioma in thur cohort. In Seidman et el's cohort ef amoaite insulation praducUcn workers, a total of 14 mtsothelisaias were Identified by death csrtifiat* or paihoiogtcai reports (Ex **-0V). These 14 deaths from mesothelioma tanstltutid ITS of tout deaths in this cohort. Cohorts of chrytotile worker* had raieUvoiy low percentage* of deaths tram mesothelioma; OUT 0907244 J Cj723 DU 028345 Federal Register / Vul. <a. o, m i fnday. November < -,9B3 / Rulrr and Regulations 5U1S Tula 1 KSOTMUOAA OMThS AflCW COMMTS Of CH*TS0TIL kC.**S Study l ef antit from raiotna)ion* keConald U*. 4*-04S*| * elnerg kienolsan it <1. (x. *-072) - altars 0.2 o.>. Qsatnt tt *1. la. 14-027) usttle mulcts O.i tuofno t 1. l*. 14-014) einers 0 Hammond tt tl. howsvar. obaorvsd a higher percentage of dtathi from mesothelioma (Ex. S4-047). Hammond at at studied insulation workers txpotad prtdommantiy to chrytotilt and to mow smash*. but not to oocidolit*. From daath eantficatM and altar clinical aattnaL 17S dtatiu (7.7%) war* attnoutad to maaottaliotM out of a total of 2271 diauii. Fato (Ex. **-lt*l atadiod a factory wtueh used mostly ehrysotil# and tomt eroeidollia. and found a high motattalioota nsk. Robinson at si. (u. 44-042) sbsarvtd 4% of daath* born matottaiiaata m a cohort wtaru the factory used tta following pticantagt* of asbestos fiber typos: cftryaotila 19%. amenta--OJ% and crocidolit" 0.07%. Ament crectdoUt* workan. McDonald and McOaaaM (Ex. observed 19% of dsstiit fraita maothatMima |oas at al. abearved 10% of dtaih* from mosottMlioma (Ea H13d). McDonald and Fry (Ea S4MJ64) observed 1J8* of doatha from mossttalioma and Hobbs at oh (Ea M132) observed 0% o(doatta from mesothelioma Tta Chrome Haasrd Advisory Fastion Aabettos (CHAF) noted that pantonaal meiathaUoma 'appears to bo most common in weaken aspited to lototitt. Iota than to mocido'ito. aad rarely or never to ehryaotdo" (Ea SO US. p. 127). t towevor. CHAT noted the lar|e vanatioo ia peritoneal meioitaUoau marukty amane eroeuloltte worhan. the lack m risk data exprtitod to tarma of oott exposure, end tta freouem Madiegeoai* of pantoaoaJ mosothetiomo. Cuatoatpacmly. OiAF auggaatad that (acton other dvsn Otar typo, such aa Char damaaaian. may bo important fur induettso of perttaoaal, mesothelioma. Fur pluurui meiulhcliumu. tta difTufennra in mortality amena eatana won nos as marked as for peritoneal mtsottahoma according to CHAF (Ea 00-231. p. 120). Summary opSpidtaiatatic Out: in luminary, then it tvidenca that all eammorcial aabeatet Cher typoa axetpt tot anttapbyliita. cauat astaatoaa. moaottalioma and lung cancer to buatana Anthophyllite baa been shown to cause lung cancer and aabeatoeia but ae mcsotheliemai have bees reported amena worktn axpeted to tnthophyiliio. For lung eancar. OSHA mows tta svidtnes fsr diffanauals to tak by fiber typ* as tsconchmtvs and (nceesistant Soma mdioo hive found that ehrysoctlo worhan havs rou|hiy tta tarns or higher risk of lung cancer compared to workers exposed to ampkiboie fibers, while ether studies have found that chrysolite workers had omawtat lowsr rsiatlve rtafca of lung eancar. Aa discussed by CHAF with regard is tb r comparison ef lung cancer risk per unit ef cumulative etpoture. consistent sittama of higher lung eancar nsk among workers exposed to cracidolite aad eawaite did net emerge. With come exceptions, compart*ass tf lung tancsr risk aiMng aoeypoUdool cohort* sxpoitd la different fibers generally have failed to control for tta fatlowing venables: Fiber concentrations. *|t distribution. and length of observation. Then vsneble* are sufficiently important determinants of artaotoo-inducad lung entit risk sock that OSHA believe* these particular cross-cohort companion* provided Inconclusive tvidenca aomaming litiferencos m earonogtnic potency ef the vinous fitara. Other latpoftant .variables that may eunfound crotKOhart comparisons are Otar tit* diitributiun*. hygienic measure* instituted by tta cumpamo*. and respirator use. Tta pvidesut for a diffarentuit in mesothelioma risk, particularly pemonaai mesothelioma, uy fi'iiar ivpa is more cunsiitent than for lung eaneer. Norcthalai*. ihis tvidenca appears not fo bt conelusivs baeaust of failure ay most investigator* io comrel for important vanoblti whan eompanng different occupational cations. Mesothelioma nsk it affected by tta samt vanabfa* that datanmnt tht dagra* of tang cancer ntk. Furthermore, masoihalioma hat a longtr laitncy pshod than eibasios-induead tuny eancar and rlsta axponcmially with Incrasting time tinea imiitl aipoiurs. uch thst length of obiarvatior it a vanablt that muat be controlled for In crma-cohort comparisons. Quysttilo la a lung earciaogta for humans. Evan tf chrysotila couid ta definitfvsly shewn to indue* fewer mesotheliomas than tta other forma ef' asbestos. OSHA tatiavss that spidamiolegic ttudit* iodieat* that duytotilo peso* a significant baalth risk to bumaoi by taduang lung caoctr and aibaitoait. OSHA bat coadudad that fiber typa ta net an important determinant of lung canctr mortality anting from ssbtstot txpoaira. Saeauit lung eaaeor is tta major cause of txetss mortality among aabattaa workers. OSHA docs net doom it appropriate to permit higher levels af expetsr* to shryiattlo than to other asbestos Star types oa tta boaia of tho possibility that ehrysotil* may tnduco fewer masothaliomii than tha ampbtboUs (amoaita. erocidelitt). 3. SffriametU Otm. OSHA bsiitvea that tsmoraua studies al laboratory snimoJ* axposad ta asbestos have found that the dimensions of fibort rathtr than typos of flbtrs ore major dstermutami of nsk tat lung distas* and canetr (Hanngton. Ex. 0^131; Pott. Ex. 04-173: Suntan. Ex. 04-43.04-133. Wsgnsr et si. Ex. 44-134: Wright tnd Kuschnsr. Ex. 4-310). Aspsct rauas (ta. loagth to width rsbos) ef fibers have also bttn soggasud at factor* influonoing carsnogoatcitr (Sartrtnd tad Faaarat. Ex. 0^114). Bacausa fiber iixs disirtbutfen appears to offset distas*. fasting potsaey. th* tsurca af the asbastaa used for laborttary expanmenu tnd tta ratthodt used to product the stbestos `etouds" should bo caatidtrad whan mterpreung lha results af laboratory experiments. Chrysolite, amaail*. sad erocidolitc have ail kiducad cancer in animals upon . adaiinistratton by inhalation, injoetion and impUaution (NIOSli. Ex. Os-UI. HtOSH/OSHA. Ex. 44-120: Witner et 1_ Ex. 04-aS; Davis et tl- Ex. 04-120). Davis et L (used that UlCC chrytotdr DUP 0907245 724 DU 028346 51U6 Federal Register / Vol. iD. Nu. 21S / Friday, Novrmtinr t, mn3 / Rules nd Rest;!,mans produced more librom in rats via inhalation then did UlCC amcsiie. Factory ssmplc* al ehrysotiie. however, produced i similar degree of fibroin via Inhalation eotepsred to factory samplst of amoiitt. u Wa|nef at al. eondettd inhalation itudiei of i UlCC asbestos lampic* 12 chrytotili. 3 imphibofe] In C/Q Wiitar rata, ana found similar drgrtrt at pulmonary fibroin and lung tumor ineidaneaa for all eapoaed poupa (Ex ae-oeoj. (The Union Intamanonila Centra Cincar (UlCC) wit the Murea for the eabealot fiber sample* mod la the ttudy.l Animal* eapoaed to the I chryiotile aempiea ratedied mueh lata duit ta thair lung* at lha and of the xpoture partoda than lha 3 othar txposrd groups. Concttmag tint ttudy. the NIOSH/OSHA Asbestos Work Croup commented: `In tanu of degree of response related to the aoantity of dual depotttod and retained la tht turpi of rata, ehrytatila appear* ta ba ueh more fibeegeeic and esremsgsnle than tht smphibolss" (Ex. **-320. p it). Of interest ware the matothilioaus occurring after otsly ana day of tapesura to amaaita and eroddoUta. Intrapleural administration af various fotau of aabaatoi produced the foilann| toddene* of mesotheliomas: crocidelitar^in. unoaita IW. nthophyilita--M*. Canadian ehrysstil* 2012. and Rhadaaian chryiotll"l** (Wspnar at al Eat. * 217].' In eontrait Stanton ud Wranch (Ex. P4-33P) did net abaorra difftreeeta in mssothtlioM laeidanea by fiber type with Intrapleural implantation. Oiryiobit may act ai a emeardnopaa in addition ta aettna at a primary eareinofen. Kung-Vossmas and Vinkmann (Ex. **-143) obaarvad a itrenp interaction between ehrysotiie adiaituitaiad Intratriehaaily and Nnitroaodiathylaauaa administerod orally with rapard to production of laap tumor* in hamatara. N-rutretadisthylamin* baa botn damoaatrated to ba caiatnopnnic to many different apadaa by many different route* of sdmtreitrstiOA la lrr, Stanton. bayard. Tegertc. Miller. May, and Kaat pnbllehed the resell* of tana af 37/Uieaat |ia*M* af vaiytnp type* and dimanaiana (Ex. **- 003). Thaaa Qbraua glqseas warn implanted in the pteanw af (mate Osbecua.Mandrt rat*, and wvhring animal* ware aaeatfiaad aftae 2 years. Statiatitai anaipMe mdiaatad that tha fibata lata dual ar tqnai t# 24 micfonnri Oias) in dlaamtar aad looser than P im produced tha hiahott incidence of pleural sarcoma*. Fiber* Icei than I um ia krutth eppearud ta ba inactivated by phagocytosis. * IPhngocytoait ta tha ingulfing nnoratpn particle* by phagocytes. which ar* eslla at thuse less ihim S micrometers Um| -.n (hat usually digest these particles in Imgtn (Fx. *4-230). Suth rtts tnd order to protect the body Irom them.) monkeys wur* exposed to t ehrysotiie Stanton at *L stated. "Sines nenpiusiic ssbestes serosal for 1* months. Th* response to a variety af types af durable surviving rsts were observed for a fibar*. particularly asbestos fiber*, was months following th* cessation of similar, our experiments reinforce the tsposurs. Neither pulmonary fibrosis idee that the eareinegcnletty of fibers nor tumors were increased in the depends on dimension end durability exposed rata compared to th* eontrol rathsr than physicochemical properties rets. Monkey* ar* bcin* maintained for and emphasise that all rtspitable fibers an indefinite period following exposure should be viewed with caution' (Ex. ** to determine th* chronic effect* of 001 p. SIT). exposure. OSHA bolitvat that Stanton at al's The N10SH Investigators tnesunimd study has important implications for the soms difficulties in trying to genera i* question of fibar type differential* in short fiber*. Th* ball milling method risk. The study suppasts that any was used I* peneret* fibers, resulting m obatrved differences In risk by fibar type may ba due ta difference* in tha ssbastst bails that eouid net meet the dasitsd 34 aspect ratio. Soma problems fiber atsa dittnbuuoa within the also occurred with repsrd to the workplaces bain* compared rather than methods af counting tsbestot fibers tnd Inherent chamieai propaniaa of tha particular fiber*. Stanton at aL't stady detartmainp aerodynamic diameters (Ex. II 230). Consequently, OSHA considers suggest* that fibroua tnatanals baaidas ssbastos can produca a carcinogen!* response in both tha pitura and peritoneum, provided that thaaa materials possess caretnoptaie dimensions. Amonp the fibrous materials damonstratad by Stamen at at ta product malignant tumor* faUawmp Implantation are: All form* af itbcafo*. Including amean*, sithopfeyiliie. ehrytatila. croadalita. and tremolite: boroatiicatr. plaia: thirtinum tillcat* (Use mtnatal wooh aluminum oxide: potassium dunata: sllicaa carbide: sodium aluminum carbon*ta: walUttonita: and attapulpitc. It should bo noted that Stanton ot aL's study did not rule out e*ranegwicity of fibar* that Platak at aL't study provides tugpttnvt but net conclusive avtdtnce that short aabaataa fibers do not indue* pelmaaary fibroai* ar tumors. Soma ehamtau have poaittd that asbettes fibers have biochemically active sites on then surface* that can be modified s* s* to reduce the haterdous poltntial of atbastat fiber* (Ex *4-2331. The titctrfctl ehtrpt *f ehamicsl group* an the surface of asbestos fiber* haa - been bypothatisad to influence toxicity af fibers. For exempt*, oca chemical pcooeea removes the magnesium hydroxide groups an the surface of ehrysotiie end replace* thsm with sllanai prong*, produsing a farm of outside of tha dimension* shown to bn ccrcmoganic. Stanton aL(l3fl) continued thair implanution axpartmanu. prastiy tsrp*nd:n| the number of durable mineral* including aabaataa. tasted via implantation into tht pleurae of faaiaia Ofbemo>Mcndei rats (Ex. PO-tM). Slants* at *L sbaanm* that th* mast carainapasue fibar* urar* those Owe tint or teas gt diemetar and yraatar than i pm In length: howavsr. high eonaUilon* with catonofctucity wer* also obscnrtd ubte* known at iiianatd asbestos, to vitr* taau (tests eonduettd on eslla in tast^sb* slmelatfan* of Uvtn| systems | have ben conducted for norms! asbestos fibers snd chemicaUyrrts ted asbestos fibort. Oeertssed toxicity m ehcmically treatsd asbestos fibers eomparsd to normal asbestos fiber* has ben reported (Ex **-3331. OSHA cp ts'ders that tha hypothesis that biochemically active site* on tht surface of asbestos fibers dstermmt the dsprsa of earetnefnieity of th* fibers ts not for fibart 24 pm or Was in diameter aad wmt tepported et this time. Tins is laeasr than 4 pm. Wright and Kuacbnar (Ex **-J10) Jbecaass many in vtv* studiss. especially those eaaduntd by Stanton et *L Ituvc tnrdiad th* production of fibrosis by foaad that fiber dimension* rathsr than Intratracheal infection of asbestos fibers ta gain** pip*. They observed fibrosis tiy from ubesso* fibart lonptr than 20 pa. Cibb* and Hwanp (Ex *+-121) chemical properties sppecrsd to be tht primary determinant of fiber exrcinepnicity. Stanton ot aL found that a variety af non-sibestot fibers could pamtrd out that industrial process** tarn* asbestos may rtduct tha indue* caacer. if they were milL-d to specific dimension*. Th* m vitro studies percesttta* of shorter fibers in the air. of chemically treated tsbestot art nut NIOSH (Platefc. Groth. Finncii. Siolb as determinative of health nsk as the in and Ulrich) conUuctcd a ttudy af th* vivo studiss ai fiber dimension and chronic affect* of inhalation *f tbon hence do not refute th* findings of atbeete* fibers, with short fibers defined Stanton et *L and other investigators DUP 0907246 j:c DU 028347 Ftdcul Repsicr / Vul. 4h. Na 213 j j.-riduy. November 4. mi I Rultt* and ReguLtUom JU17 concerning the overruling importune* ul fiber dimension. Therefore. OSItA will continue 10 include uhcmic.iUv-trvjied asbestos longer thus S micromeiirs wnh a 3:1 or greater aspect ratio in the teape of tht siuestoi itundvd. on the bam that ehcmtcally'trealdf asbestos posci a health nek similar ip (at of uotrtstad atbetto*. * In luminary. 09 LA retard* txptnmantal ttudiea of animals ai auQtsiiag that all aabeitot fiber types peaseu similar carcinogtnie potency. ArumaialudJie alea suggrii that fiber dimensions rather than chemical properties or fiber type may bo the strengtsr determinant of carcfno|*nicity. in OSHA't view. Extrapolation of the results of axpanmamal studies in animals to the human experience ntcessilatM so atsumptitn that the fiber dimensions used for sxperimsntol stiidtts resemble flbor dimenaioni ia workplaces. This assumptioa might not bo vebd ta ail inaianee*. 4. Ocher Actor*. The various types sf ssbostes fibers may differ ia the percentage ef fibers available foe inhalation and the length of tlms that dual clouds remain airborne (Kowe.Cs. 14 Path Croeidolite might itay airbeime foe a longer period of umo sod have o treater number of reepirabie fibers compared'to Semite. which in tore my tseepd aathophyllito in regard to theoo two characteristic* (Muir. Ex. *4-JM|. Tb* preparation method far ehrysotll* will determine thaeo two characttriatica foe laboratory sample uf ehrysotilo ar for a particular workpUee wit* chrysolite axpesutt (Row*, Ex. *4 <011. lacausa thicker fibers encht drop to die giound faster and erucuioiua-t* generally finer than the ether fibers, croadolito use might loud tu dustier work sfivironoMM* and hnner a areater health nek. avta if aroeidolite ia oat oiere dangerous an a (ibef-for-Cther beiii (Muir. Ex. M-3S0I. However. moat rsspt>utili! fiber*. which are the fibers iikaly la cause diw.isr. will lend to remain airborne fnr limp periods ef time. Another point in asuutliv ia whether, (ar different filter types, the ratio between fibers t lattdr antler a micraacape and Hlti^-fine subaucrotaipu: filters runes. This would eonfiwml cnoipunww tuhwrro cohorts ipparmtkr npmd to tho unto iovete tf differmt vuddn Mirra antler the tight ouamtiiitw. d mtirni tifim not counted by the yryot upra-d sdcrascwfy arthwl |o* a keMid to health (Mum. I'x * x.`il OSIIA Itrltrxrx that Um kff ftl<r<*e>r found III mimnc u* dl'n ami Ihul ebavu'inK aunttl K luime l* twara lend to lin'.tk IlUxx a|wl Mkl inke.0 their dt.imaim Based on xpenmrn!ai findings iRipncaiini long thin fibers as Lh-mj inr musl wtrcinogunic fibers, (hetv lubiutiucm procasses may have a grtuirr carcinn|<inic huxard compared la thu initial mining and milling operations (N.eholson. 19S1. Ex. PMJn). OSHA examined the qurstion of differentials in carcinuianie nsk among manufacturing preetssea which full under OSHA's lunsdiction. Aa la the ease for studies ef fiber typo, cross* cohort comparisons of procasses should control for the following variable*: fiber concentrations, duration of followup, duration of exposure, and ago distribution. To account for tho variable of fiber concentration. OSI1A compared the potency factors for lung eancer (KJ ef different manufacturing studies because patency factors are baaed on nsk ptr utut dose. As discussed in Section V, Quanutativt Ritk Analytic the potency factors for lung cancer wort not consistently higher for any psrticuler meniifsctumg process, leesuse potsxcy factors for meaeiheiiea* IK.) could ho calculated for only 4 studies. OSHA could r.ot compart s to. diffbrent manufacturing processes, ta summery, then does not appear to bo a consistent pattern of diffareaual lung eonear risk by manufacturing process. Therefore. OSHA deems it appropnste to untieaa ta apply t singls PEL to all segments of industry eovartd by tho Ageacy. Rtlauvtiy thtcfc respirable fibers tend to ledge m the lung white thinner fiber* eon travel ta the periphery of the hug. and penetrate and then lodge in the plturs. Tboao fine fibers lodged in the pleura might be the *nducen of metstheiioma (Nicouison. 1S01. Ex. IS* orrr gignoo at aL (Ex. Os-IOOl studied the lungs and plau** of shipyard workers. tod found larger fibers, tspecially imphiMle*. w tho lungs. In the plows*. fins and satail fiber*. Mistily shrysetil*. were found. In summary. OSHA recognises that the fiber typos may dUTor with regard to their tendencies break into fine fiber*. Croadolito aOf*an to divide into finer fiber* mar* readily then other asbestoe fiber types, which may render It men taurdovs. Manufacturing practise* could increase the earonogeniaty of asbestos by generating fiber* that ar* thinner in diameter (dative in mining and milling process**. While these farter* ar* intare*ting and eoninbats to the fematwo of hypotheses regarding the mechanism* o< usbestu* curcnuatensns. OSHA believes that dim* factor* d* nut provide a definitive answer lu thu uiarslMin nf pntsilil* MwiimIi ia rtak by liiin typo. OSHA virw* ihe data front cpidumraio*<c and experimental studies, which have ulisurved excess cancer nsx from exposure ic all ssbeslus fiber ivp.ts. as being the most important wan retard to the puesnon of differential health nsx by fiber types. ' I. Tftmolii* and Andiop^yUita. Some but not ail commercial talc deeostts contaia sarpontuio aslwstet and fibrous smphibol* asbestos, mduding ehrysoui*. tremolita. and anihsnhvilite (Oemtnt and Zumwaid*. Ex. M-43g|. Kleinfeid at aL (lggr. Ex (*-!(!) atuditd tht proportional* mortality sf ta uie minors and sullen to New York State who hod bean exposed to asbestos contained in tale. All men were employed during tMO and had IS ar more yarn of axpeaura during JS40IMS. Of ft deaths in the study cuhoru 10 01%) wart from respirttery system cancer sad 2S (31%) war* from pneumoconiosis ar eempifeation* of pneumeecniesi*. Kleinfeld at ai. eaiculotod that only U (33%) deaths from respiratory lyttom esacsr would have been expected. resulting in * greater than Wold risk sf respiratory cancer. A follow-up study by Klsinfeld ft ai. (!?4. Ex. SM41) included 2S0 workers axpeaad ts asbestos in talt.Of the jot deaths observed. 13 (U%) ware (irea respiratory canctr compand to 4 (17%) expected. The high proportion of deetka from pneumoconiosis may have redeesd tho lumbar ef deaths from lung eonest. Kivtluoto at aL (Ex. S4.1S1) and Nurminan at aL (Ex. t4-tr I obttrvad pneumeeonieaia and csaaat lung cancer msrtsbty among Fiaaiah worker exposed ta tales containin* fibrous enthophyllite and fibrous tremolita. No daatha from ewsothaliama wero reported by theso investigator*. Yasidogi*. Ilcayio. Sale. Saylt. and Yarulmet (Ex. *4*3111 reported a high prevalanes of piawel calcification and thickening sad a high mortality rata from mesethslismo among rtsidtnn of Cermik. a town ia Turkey m which there are auny deposit* of asbesttform mtnorala which are used at construction mawriais. Tho eenstnictian matanala Jievo boon shews to contain fibrous tiemolite. antigont*. Uaordite. ehlento. and talc. Yaziaoglu at aL alto reponad an excess of lung saneer in this population. Irena. Oemont. and Wagoner of N10311 (Ex. P4MSSI conducttd a histnncai prpspeclivr studv sf ulc miner* and miller* *1 one company in New Ynrk Slut* reported by the company to bo mteing tales nat etmtuininc asbeeto* emnuruis. NIOHH (Oumeni end Zumwuldet. howevrr. h:td reported asbestos exposure in the talc DUP 0901247 GC726 DU 028348 Sing federal Kcsuicf / Vol. 4& Sa. ZIS / Fridny. November 4. I>i3 ( Rgloo jihI Rnrjf.iriore aun* and mill. NIOSH conducted an bidtiiinel hygiene survey o[ the study tale mm* and a attgiibonng t.ile mm* knora to contain asbestos fibers. Silica exposure* were found to bo vary low. wail beta* MOSM'a rmremmanded PEL fur silica. Radon daugifar meesurememi made b tit* Mina Enforcement Safety Administration (MESA) ahowad only nil to tfaea level*. Dement and Zumwalda found that exposure efcaraetanauea between the itudy ame end att|hbonn| mute ware aubftaedaily ii/iuisr In feet Ota aiiiama duet umplea fra* tke mine and mill tmdiad ky NIOSH and oemteiatd by the company to Pa etbeetee free warn found la aoaiaia a k&tr proponlo* ef gosiuvttr identified asbetufon* amakibalaa Utaair due la a kieltai liwMliia aaniem. Ail other fiber eharaatnauca. lack till median lonedb diameter, aiaaei ratio. aad praaanlen lace then Ilia langth. wan net ttatftiicoBy drffarent at the U iavsl* (Ex. ae-tU. p. 10). The NIOSH study cohort (Brawn at a!) aonetaiad of ell white maiee employed aomedme during 1*47-1*33. Vital atatua of the 333 cohort member* wee determined aa of ftute 30.1*1 Compartaion wea made to ate. calendar period, and eatuwapedfic mortality ritea of VS. white melet. Significant tr.creaaee in lung caaeae Banality (t abeerved deaths vorua U expected) and MtwmsUnant raeptratory diaeaaa Banality (I observed veraua 19 expected) wan ebeerved. One death bon actothtlioBa occurred. Slnca tha individual who died from mesothelioma had pnmouaiy worked In the eonstraction industry, hie death could not be definitely aacnbed to hie expoeura u . ..r.ollta or anthophyUite. Of the 10 Individuals who died bom ntpiratory syttaa cancer. 3 had previously worked foe ether New York Slate talc companies. NIOSH invetugatere alee addressed the potential confounding affaata of ctgars.U amokint la thtif opinion, a cohort of hoary smokers would hart no more than a atw increase in keg caaeor hah (a relation to ell U4. white melee Because they observed a treater increase in lutt| caactr itch, abnoaa a 9 fold risk, they fudged that cigarette emoting wea unlikely to.acamnu far the observed excuse tag eeneerriak among these tak ariam and aflfcre exposed to aibeetoa. The ewito sectional morbidity tarray anthemed by MOM In 1*7* found e prevalence of amohtnt- e prevslenee esmthnr k that ef ILS. outke. Brawn. Dement tad Wegener stated' that "exposures to eebesufono tremoUte end enthonhyllit# atend out ea the prime suapeeted ctielcgie (actors'* eeeecwied with the abeerved excess rtiks oflung c-mccr nd respiratory disease. They concluded that 'exposures to tlc from the (JouvemeuT mininf ares are auocuted with an increased nsk of bronehofenie cancer end non-mnliptant distil 1*1 of die respiratory ayatem" (Ex. 44-1*1 j. As measured by optical microscopy, avarsfa air concentration* of liber* (rastar than S um in lentth rented from VJ f/ee to 34 f/ee ee an 3-hour urn* weighted ovtrsft for 3 different job titles in the mine, la the mil sverete air cencsntreuons for aueh fiber* rested from 14 f/ee to 14 (lee 1* an 3* hour time*wei|hted everefe for it different fob title*. (Ex. i-i3i. pp. 7-10L In addition to ih* axcaa* mortality from lunf cancer and netvmaif|naat reaptratpry dtaaaaa observed by KJoin.'cld at tL end Brawn ct ol. numerous studies of isle miatrs and mtllare axpeaed te asbestos contained in teles kava established that these warken have e hi|h prevalence sf pleural thickening. pleural calcification, decrements in pulmonary function, tad libreeinf hint disease (Dreeestn. 1333; Draaastn and Dalla Valle. 1333; Sietel at tL 13th Schepere end Durban. 1833: Metssta at aL 1333: Weinfeld at aL 1333. 1334.1434.1934.1933.130.1173: Meurman at aL 1174: Klviluote at aL 1334: Ahlman ct tL 1973: Bom at aL 19C Ex. M-ink Many of theta studies rare conducted in the same geographic tree at the studies by Brawn at tL and KMnftld el aL A crotf-eeetionai morbidity etedy ef the seme company wheat mortality experience wee studied by grown aad colleagues wet performed by NIOSH investigators (GomHe. Fcllner. end DeMeo. Ex. 34-111 (. A* discussed above. NIOSH considered that this company ! workfo'-t wo* exposed te asbestos eoeteined within tale. N'lOSH observed markers w asbestos exposura hi the lungs of these workers in addition to nopsratory eyaptonu sad lung function decrements. Of 113 male miner* aad aillnre. 121 participated in the survey- Respire*ory questionnaire*, chaat X-ray*. and apiromeute teatatg were administered to participating worker*. Campaneen el respiratory morbidity wet made to 9347 eoal tuners. 10*7 potteb miners, ehrytoul* aibeetoa ureriten and tynthotk wool textile worktre OSHA eontidere that one of the mater strengths *f Camble et al'a craee-tectionei morbidity study wee the choke ef eampeneon populations. Beeaue talar eael. and potash miners an likely to be similar tn many non* occupational factors that may effect respiratory morbidity, the likelihood of observed differences in respiratory turbidity being due to specific workplace exposures of the tulc workers rather than other nsk fusion for lung disease is greatly incressed. Companions with the eoal and potash miners were siMtifii-d by age. height, smoking tiaras, and duration sf ' employment m mining. Compared te cool miners and potash minora, the tale worker* with no preview occupational exposura within other tale miset and mill* had statistically significant increase* in pltorai thickening and a higher prevalence of pleurel uldfication. When all tale workers were combined without regard te previous occupational exposure to tele, increased prevalences et couth, phlegm production, dyspnea, piesrel thickening, pleural calcification, and Irregular opacities ea the X-raye were abeerved in tale worsen compered to oet or both mining control groups. la addition, tak worktre had significantly decreased pulmonary function (FEVl and FVQ. Oeereaaed lung fuaodon we* aaaooated with increased cumulative expesuree end lengths ef exposure. Tele worktre had t similar prevalence of raeptratory symptoms whan compered to ehrytotilo asbestos workers and a much higher prevalence of symptoms when compared to synthetic wool textile workers, ha contrast, piesrel thickening was four timet ea eematea in tak werkara compered te tha ehrysettle workers, lacking wet not found to b* aatodatad wtth the observed radiographic change* La tek workers. Regarding their studies ef meabidity end mortality of worker* exposed to tale cont*inht| eabestea. NIOSH concluded; *A thereogh review ef the tvetiebie Utenrare ONMOSBottd that fiadings sf the present nudes ere to aeoemani wits mas* ef ether studies of occupetieeet ereueo pend to tha um or stoulor auiwrois or mlntret mixtures. This to ttptciaUy tree for looiialiiirwl sxpotom te iotkephyUit* asbestos. These fiadtai* make u tmesrstiv# that workws Pom tho sites and mill stwdird. harem. bo rewtsoty oPeorvcd stiae snodical sorroiiiuMe entaeia amablittied * the 0W1A aad MSHA athatwa suodard. FurUmort. all pravtilwit of thota sundaida should bo fallowed Ounag tha producuoa and suPatyiont uo ( thaw vat**' (E*. 4fei*t. p. 33k Still* end Ttberehaw (lx. 34-1341 of Tahenhdw Oeeuptnenti Medicine Associate* tmdiad *U mala workers employed somtum* during 19*^1977 at tho tale mint end mill studied by N108IL A total of 703 mm were eligible for tho study, end vital status aa of December tL 1371 wet ascertain*!i for 172 ef the men. Of the 70S men. 33 DUP 0907248 JOG? DU 028349 worker* wtr* excluded beeaue* of lack ot information on specific veneble*. leaving cohort of Ui for tnelytia. Comparison was made to tge. calendar period, ind ea use-specific mortality rates of U.S. white imIm. Tor tht ovtnli cofiirl tictiiet in mortility that wart notltatittically significant wart observed for lung eaneer and nen-malignani respiratory diiaasa. Sulla and Tsbtrihew judged that the aoo-signifieanl excess of lung cancer was "consistent with a smoking afTect* rather than an affect Inn occupational exposure (Ex. M-lft p. an). Stifle andTabarshaw alto acparataly analysed the mortality of the talc workers with a history of any work experience bafora employment at the stady mine and mUL This prior work experience included all piavtoua fobs, not only (obi at othar talc minac and nulls. For this tubcohort of MO white tlaa. moruliiy from the following causes of deeth was significantly titva led; ail cancan (SMKwlKl liver cancer (SMXalOU). respiratory system eaneer {SMBM). lymphopoietic cancer (SMRJ74|. and noa-meiignani respiratory disaster (SMKse307). Stilly and Tabtnhsw stated: "Sine* the cucm and lung diststss typically bava long latencies, the possibility sxiata that axpoauns prior to work ot tat TMX study nine end mil were responsible far tt.least some sf (bass diseases' (Ex. M-tM. p. 03). Whe* tht msrulity of the subcohert with no work experience prior to employment at the study mine and mill was analyzed, ne cause! of death were in exeert. in fact, the SMR for all eauaea was significantly decreased (S.MXwlO). Aa weuld b i expected, this cehon was tnertlly younger than the cohort which ed previous work expertenet. Stille and Tabenhaw eharaetented that* Armings at follows: (11 "Weeken with 'exclusive' TMX (study mine and taiil) employment seem to bo ot no considerable risk of having lung eaneer develop" end (2) "tipeturtt ot TMX warn to be nenearcmogeaie" (Ex. M IN. p. 413). Brown. Beaumont tad Oamoat of N10SH commented dn SUlle ind Tebenhaw's study (Ex. **-210. p. 17*: Ex. 04-33U lifting several problems is the analysis by Suita end-Tsberthaw that could aeoMM for the different conriuslosneftioterasetsof inreetfgaton. Ftm. Sidle and Tabenhaw faded to oalyae mertelity by length of foUawng latnsey interval). Brawn at aL thossttht tuck an aiutlyti* wee particularly important slvms that recently hired workers were allowed to enter the cohort ee lute a* one year before the study cut-off dele for vital occupational sipoeura -t tho ttudy status dffenamttion. Second. Brown tt si. commenttd that plant. Tabenhaw end Thompson also posntad out that only one taic miller S1 -He stid Ttbcnntw division of the study (Toup into subechorts with *nd developed lung cancer, despite the historically higher exposure* sf (tie without work txptncnee pnor to their employment at the ttudy facility ntulied in "selection biases iiuieraw in the definition of the subeohorts" (Ex. sa ng. p. 179), The selection biases which tendtd to lesson tht tutitticel power of the tubcohort without pnviout work txpenence included the thon length sf followup, short durations of axposure. and small else of thn tubcohort. Brawn et al. suied: "Any mortality analysis bated on such a small cohort with gentnliy short latency is not likely to be very informative'' (Ex. 04-nil p. ITS). `mid. Brawn at el cnBclted SUlle tad Ta berthsw's analyses concerning the duntien of employment of the lung cancer cate*. Theee analyte* examined the observed lung cancer deaths without calculating tht expected number of deaths for tach lattncy category and millers. In conclusion. Tsbtnhsw end r Thompson stated that spplicatian sf the etbeetot standard to the Vanderbilt workforce wee unwarranted besed :n current evidence. OSHA calculated a statistical power of tin to dotoet a tO% inert*** m nek of lung eaneor in Still* and Tebenhaw's tubcohort of worker* with no prtvioua work txpenence. (Set Ex. IMX for t description of how OSHA calculettd statistical power.J OSHA considers that this vary low statistical power supports NlOSH's enuci-a sf the sensitivny sf Stall* and Tsborshaw's study design. Tb* statistical power would have been tvea lowtr if it bad been calculated for the group of workers with st least to years ef latency. Aa discussed earlier, omst-cohort duration of employment category. In campenson msy be pnblentitic if the addition. Stow* ot al pointed ast that eg* distributions, derations of exposure, SUQe and Taberehaw'e conclusions had and lengths of follow-ep differ among ast adequately acknowledged that many the cohorts being ceapsrad. OSHA study facility worker: bad been believes that this sppesre te be the east employed by neighboring tale with TOMA'S cemperisan ef the companies with exposures similar to tubooharts with tad witheut previous thooe of tbo study utility. work experience. Irawu ot al aeachtded that Stills and Taberahaw't rtpen did sot adeptsteiy tddraca the question of increased king Several points art notable with regard t* the qoeatiea ef the then-term wetken wh* develeped lung cancer. eaneer risk from working at tho study First, short durations of expo*are may Utility. In addition to tht points discussed above. N10SH also commented that death certificate* hculd have been coded icurding to tht rules of the ICDA in effect at the time of death and then convened to either due rth or Sth -vision o( the ICSA for anelytis. tether thon coding the death* directly t* the Itb revision. MlOSH else hid questions concerning (he S3 worker* tiimsnetid from the cohort and how workers lots to followop worn trotted in the analysis. Tabenhaw end Thompson raepended to the N10SH cr.tiqat with the foilewing OMBmenu (Ex. M2t<l First, they cited minersi tdendtis end liboretonet who dtaagroed with NlOSH's method of identifying tsbettet in silicate eUneret hum and whe did not find significant asbestos concentration* in the talc processed et the mum end null, foeoad. they staled that talc an et the stady facility woo not similar to that of other tele mines of upstate New York. Third. Tabenhaw and Thompson reiterated that many of the lung cancer deaths occerrrd tn short-term worker* employed for less than one year. In their opinion, this lessened the likelihood of tho lung cancer* being tttnbuubio to rotah la high cumulative dam depending open the intensity of the exposare. Second, the phenomenon of short-term aibostoe exposure end subsequent disease bat been observed in other epidemiologic studies. Third J the majority of p ln-ytan-et-nsk were contributed by short-term workert. thua finding most of tht lung cancer deaths among these worker* would not be uooeual Also. Tibershsw and Thompson did oat discuss tho exported number of lung eaneer deaths whtn they mentioned `.he single lung einctr death among the ttudy fetility tele millers. In IdU. Consultants In Epidemiology end Occupations! Hesltb (CEOH) prepared another analysis ef the mortality of Still* and Tebenhaw's study cohort (Ex. 90-2J7). NIOSH reviewed CEOH's intiysis and stated: "Although the findings of these analyse* appear to support their ICEOH'sl hypothesis that ih talc it n*a-carainegtni& tht resuiung statisticsl enalyeas ere based on tuampUam. tneli number*, end short latency. Therefor*, ih* CEOI i conclusion* era besed on enelyse* ihat tn inherently deficient in being tuie to DUP 0907249 DU 028350 S1120 federal Register / Vp|. <g. v<a / jr^day. Novemlirr 4. 10S3 / Rule* and Regulation* detect i true nak m in expoirei population'' (*. p.3). South. Hubert. Sobd. end Marquet (E*. J4-WU! ttudied health effect* of Lie containing ttbaates in Wboretory tmmal*. Srmtb el tL ernnauatared intrapleural Injection* ft 4 different trameltiie lubutncei Wlo bamjtara. including fibrou* utmoiitie tale (ran New York stale. trttnolite prepared from tremolitie t*lc are of ih laetlity ttuditd by NIOSH.Vemoiite prepared from welters U tramoime ule ere. and aibeetifom tremalite. Period* of sbiervttion rented from J30 day* to MO dtyi after injteuan. Tumor* and pleural Rbrett* were ob**.>*d only la oniaieia mjected with aibaitifarm trtmoiil* and trcmoiitt prepared from weatara UJ. rramalitie talc ore. Smith et at found tbit the tempi** af atbaatlfarai traaalitit had |re*ter proportions of Ion* thin fiber* than tie iimpl* of tremolito from tb* facility itudied by NIOSH. . Tht umpit of fibre** tremoiitle tola from New York tuta alto contained loot thin Abate and South at tL tuggttttd that the nttetive mufti from this particular itapie were duo to ita sued iawar mrmoiite content relethat to the aaremoptme templar. Smith at *i respited that the cample af pemoiiie from the facility ttaditd by NIOSH may biee (tiled la indoco utoun Ntwei ai the ahortar length of ita Aban. dtapita iu high trtmoiil* aaatent. Camstonting te thttr retuiu end art the feet that the earemoftnie umpire eanuirod maurial athae than tremalh*. Smith at ai. atetod: ** * * we ataoaf be ir* that tfcatt ctivily r<*uil r mn t pert is tmnoiifs ' * * CSfUSiilfdliM tvst tW *M owi.iy te tki tmeui at oemolue. tmi die te ether (actor*, tuck a* tha Mntilna charecteruiidi af the aUiwrat' (Co. **-t*. % sat- OSHA contidan that interpretation af Smith at!.' finding* to limited by tht mail number of antmalt itudied. then urvival ttmot. end then penodi ef ehtervitian. in iwumary. OSHA randodea that NiOSH inidle* have ibeura that tapoourt to iibeitb* when tt it prciont ta ule ippton te hate mailed in cxceo* mortality Cron tad aateotaad aM-maUgaan* reapwatary dt*aa* and xcom rt*k of pieorci thickening tad lung funetlea daoemeeto. OSUA it cartit*at ef the Cm that talc attain* and milling ia th* aboonce ef aobcatoe exparara ran retail ia fnvnireacanjuau. Funhermera. NIOSIT* fisJinc* as wiaiiiy ore eonitent with thoo* of Klainfvld tt tL Klvltaeto at uL Nurmtncn at aL aad YoaicmitM at *L f'lOSITi aturbuilty finding* arc continent with thaaa af aumarov* ether croeideiita ami tmoatit appear to h.ivt ttudiaa. OSHA believer ttutt ih* had a higher proportiun a; dertn* from `P'dimiolofic ftudy of the Lie company mciothaiiom*. parttruLrly peruoncii conducted by Sidle and Tabcmftow af meaoiheiiemt. compared to Tiberihiw Occupational Mrdicin* oceupattanai cohoru axpotad la Aetoaaic* ha* wnoua iimitntiom lueft ehrytttile. NanethcJtu. OSHA u unai that it data net refute tha hyputheiii to chtraetartu tbit avidenu at that tile eontmning iibrttoi poiei eaneiueiv* beeaut* men invntigjtor* lung unear haurd to repoud worker*. failed la ranml for Ebar eonunirution. Smith tt at'i experimental *tudy length of ebaarvattaa. and rg* ebaarvad poaitiva finding* of diiinbuuon wh*a miking croiKahon tumenganibty fat aibtatiform tale and eomparioona al mortality from aan-patitiva rinding* far tha tale from attothaiiama. ControJiiag for iangth of tha facility itudied by NIOSK however. obtervotioo it partieuiarly unpertant OSHA think* that limttaaaa* ef Smith at bauua* metotheiiomt uaualiy hat a al.'t Hady render iu finding* ittaney parted af 10 year* or mere ami tncondunve for talc from tha faeiiity th* h*k riir* txpanoniinUy with ttudiad by NiOSii la any event, the inertawag lima tinea initial txpeiura. poaitiva human findittft outwoi|h tha Lung exaear i* the major eauta ef aan.potttiva animal finding*. Tala nbattoa-induced occupational antniaini rtbetras mioarel*. therefore, mortality. Moaothaliomt end tibrrciit appear ta peia a aigrefleant health rlak to axpotad worker*. and taie worfctra tioo ore tigntfleant cauiai of txetsi mortality among t*be*ta* worker*. axpotad te aabaatat thaaid raemva the OSHA M* eonciudtd that there u a protection afforded by tha tabettea |nvt rtik far lung eanear aad aibrttoiii ttndard. OSHA aeira that the broader among werkar* axpotad te ali atbaatoa lame ta te which mineral Abort ora to Abar typo* and ihii workar* natd to be be included ia the definition ef aabatot will be pan ef tht rulimakinc for tha permanent aundard. Tbit ETS action doaa net chant* the dofinitiaa of ttbeatet a* found in inaiom. I Summary. The avideae* waatmJy prettetud from that* rfeks by thi* ETS. which aeu tha lowait PEL that ia ftanbla ai this time. Aa t praedeai regaiatory endpoint, therefore, it 1* iacaotooutottal whether tha ntiMthtiitma tbk it greater for etrtahi bafart the Agoncy iadiaia teal ail oabeataa Abar typo*, except for aathophyilii*. ante font aoat. meaothalioma. and aibrateait. Anthepbyllile axe** lun| eaxerr aad. tthtttotia. M*oti*!iema hat not boon raprata* In anWaphy!Ut* worker*. . Far tun* cancer. OSHA oataa that Incmniaicsi tad incendufivt fmdtnia with rtiord te difTcrannai rtik by fiber type havt been ebta/vad t/ difftront lnvntijaur*. Son* atadtat bava ebaervad the wnr or hipnar iunt uicir ntk m chryaottlejvorkcr* compared ta werkar* axpettdteamphiaeit Attar*: athar ttudiat abttm Iawar nak of foof cancer in dirytoti/* wrriare. For example. hi*h wapiratory earwor ruk wat oboantd by Oament and coilaaguaa urtortf ehryootile taxula werkar*. Aa dforaaaad by CHAP, caniutrnt panama of higher lua| eanear ri*k by fiber type dal oat *mar|. With tom* aacapilant. wveaUiater* fenenliy feiiad to cantroi far vanabieo wfbcltna lun* canerr hak whan rampannt the mortality af different oeaupauanai cohort*. Amonj tha Important drtormmenu of lun* eanear rtik. which war* not eontutently eoarruiled for. are fiber eununuation. lunatli af obfcrvaiiea irui apt dutributiun. OSl b\ new* tvideoe* fat differential v Abor typo* than for *th*f typo*. Eawruntnttf luidit* ef ithnui* hm fouas that thrytotSa fa at lettt at potent a cardnegan x* athar aibetta* Sbar typo*. On* rtudy found that ehryaotii* wat more eircinogan'e than athar atbaatoa ftbari whan idminiitared hy inhdation. Many axpartretn'.tt itudiet have reperttd that fib*.* duaonaiaa U a varv tmportont dttermlnant of eareutogenidty in laboratory animal*. Hbrr* lrngr than 4 mieromamra (unt) and with diameter* ef IS um or iota have bean implicated as the moat earciaaganie Abar*. A variety ef different aalxrai and lyntheue ubiUnee* hiving Gbart lonstr than 4 um with width* of 14 um or let* have induced eanear* via unpl-mutien in laborutory tnimaia. auegarting that the chaoueel ptopertfa* of aaoaatea iiuch .n Abar type) and noa>*ib**to* fiber* may not afreet eardncgcnicity but that fiber dimenaion* may determine carcinogenicty. Thu*, in OSHA'* vie*. taiatal itudtti do not tupport th* hypotheti* that there are difference* in earemottenic potency among th* venous Abar typo*. Fiber types may differ wtth regard to the fiaeataa of fibers used in induiri.il procrato*. Finer fiber* may be more maMtheUamu rtik by fiber type at earoiaapefue. aceording to animul > aumnativ* yet eat eixtduiivr. studio*, and etocuioUtc uppenra to be . Octupatiuiwi eohortt expoiad t* divided more readily into bna fiber* DUP 0907250 J 0 C 7? DU 028351 Ftdtnl Reyitttr / Vol. ta. So, m / Fridiv. November 4. 1983 / Rule* snd Rcaun'iona jiiji then other asbeste* Tiber type*. Alia, manufacturing processes mey break fiber* apart te generate fiber* thinner in diameter than ihoaa found in lb# mmini ind milling prse**l*. S'lOSH sciential* (Sown. Oeaem. and Wagoner) observed ncaiivt mortality from lun| cancer and son* malignant respiratory disease mon| wori.tr* in on* plant axpoatd to tale containing aabctiot. A morbidity survey of tha emt plant found increased rftk of pleural tiuefcanmg ami lung function deeremeat*. NIOSH concluded that instated rftk of lung canctr and non* malignant rttptratory diaaaaa w*t appartit in work*** expostd to tale containing asbestos. Klamfaid and ceUaaguaa alao ebservtd uuu lung uncar and ntptratory dituu mortality among worker* txpotad to tala wntatning aibttio*. and numaraaa morbidity turvayt have documented respiratory diitai* utnui among tale minara and miller* expossd te atbattot. Still* and Tabarthaw condueiad a itudy whisk they interpreted aa contradicting NlOSifa finding* regarding txctiaive mortality among talc workar* axpoaad to ubaatoa. SdUt and Tabanhow'a anidy had aarioua xvrthodalogic ** limitation* inch that NIOCiTi eonchidana mill ippitr to ha valid. While aai til laic products eontala asbetio*. OSHA find* that whan aibaatu atsar*1* are conuinad in tale product*, that* appear* to ba a boalth rtak ta axpoaad workar*. Practical adminfatntiva a*adtntion* *l*o re pertinent ta tba QUMtion of staking regulatory diiimetioe* by Qber type. Several types of aibtttc* may or ,"*unt in tha im* workplan. it the cats far insulation, snaking considtnbi* mtaaoramant difficult!**. Oattrmining aibaito* typafa) within ueh workptau aught eompUuu omnplianea and axpotun monitoring. Howavtr. OSHA it aware that tha Uoittd Kingdom ha* beta tbit ta avareomt mch eomplicaiteas. la tummary. OSHA concludes that an tba beat* of the cptdtaiMegic and experimental itudia* reviewed above, it la not apprepnaiu at thia bate ta make diaimstiena by HbOr type for reguiatary purpose*- Aeeordinttiy. guantiutiv* aaal) * of nth aha*id bat* emanates af non risk Ml asbestos fiber* at a whole ratter dre* a* tepsnta fiber types, Provmsw* af OSUA'i tttndard far ubamoa. mrhsdtei tha perauieibie txpssare limit sbsatltl alto ba tha tame for *Q eummrrierfly aaed atbeataa Tiber type*. F. CanrhanHui AtU-miw pu*e* gruvr danger to tha health of M'w<i worker*. havtag caused axcoMCiortality ind ditubility from lung canctr among workars >n tpidemie proportion* imons iomt receiving relatively low eumulttive group* af exposed worker*. Asbestos exposure*. Watil *1 *1. ind McDonald it cauita non-m*!>gn*m rripirstory. si did not obsarv* meressad lung diitai*. which can rtiult in complete eaaear mortaltiy among workars diubillty *Hd dealt). Aibeiio* auo racaivutg relattvtly low cumulative r uuari malignant ratsothtliom*. which exposure*. Dasptta soava ineonsuiancies la uiuilly rapidly faial. and lung canctr. in fadings regarding n*k from iew which it uauaily fatal. Tha eam*I cumulativ* txposures. OSHA eontidari rtUtienthip bctwttn tibrtio* *xpe*ur* that the many w*ll<eaduettd itudia* and diaaaaa haa been ratabiiahad by a which abaarvad substantially meraasad multitude of tpidamiologie itudia* risk af morbidity and mortality ameng conductad throughout tha world. workar* motiving lew cumulative Including tha l/tuiad State*. United axpoiuras art evidence af significant Kingdom. Canada. Australia. Italy, and hazard at exposure* allowed by the Finland. Furthermore, tabeetot ha* bean rusting PEL Section V,, Quan 'utatn t Shown is cause txesss disetit ia many ilisk Anaiyiit. will discuss predicted di/fsrtm occupational environments, risk from expaaun to OSKA'i PEL starting with mining and milling af A aaaaber af investigator* have aabestea and continuing to causa auatatad that different fiber type* of distast In various man/acturtng prscasiaa such a* ashssto* taxtilo aibestoe hava differeaca* m their ability ta tnduet mmathtlietna. Specifically, production and aabaato* camam erocidolite has bean hypothesized to be production. Aabestea alto ha* baan shown to b* axtmtely hazardous whan used at a product by insulation workers and shipbuilding workar*. Numaroea tdantific organizations sad agendas have reviewed the health data for asbaaioa and hava concluded that asbestos oxpeeure cause* hog caacsr mttethtUaaia. tad aabeiMai*. Ta datamlaa tha patamtal ofa hazardous agent ta cause diaaaaa at lew exposures. OSHA haa <xamixed tha results af studies af workar* receiving law expatore*. whan tueh studJt* art tha aia*t kaxardous type af asbestos bcaua* of luggtstivt svidiacx that indicat** that the mesothelioma ntk may ba higher for crecidoiita exposure than for ethtr aibestoa type*. All eoaaaereially s*d fiber type* bar* laducad lung canctr. mtsoihtliemt. and asbestos)* in axpoaad worker*, axeapt for antbophyillta. which ha* inductd tang caactr tad aabettotia. OSHA rtgarda evidaaca foe digareattals by fiber type in laag eaaear risk and asbestoci* riih u being taeonduslu* and inconsistent. However, tvtdanc* for available and have luflhtiant aanaitivity to dsttet exeat* risk ef distast. OSHA ba* also attempted to predict risk at law xpanres bom ruk ebsarvtd at high axposam by using dasa-extnpoliuott medals (see section VV Both of there method* of rvsluaung risk at low exposures art valid. Stadias an no' cvaiiablt of workar* sxprssd relaiy tnasbestoa l*v*l* of t U ec which have sulfidant cohort its* and long enough follow-up period* to permit abasresttoa of ineeata* in earner and lung direata mortality. Stadias are availabi* af worker* with law eaauUttva exposure* ta asbestos, hawavar. Workar* axpoaad SO yean ta tha OSHA PEL of 2 f/ec would hava a emauUttv* oxpoaure of 100 f/oc-ytare. fiber type diffareatiala in ntk with regard la induction of mesothelioma, particularly perttancai mesothelioma, appear* ta ba man eanamenh based on tpidamiologie atudita ef occupational cottons txpasod to different fiber types, lacauaa variables that affect tha saeaiUvity of ttudiaa for dttaction of risk ef aaaothelioat hava not bttn eaatrolltd for by moat iavtstigitor* comparing different eceupattenal cskorta. OSHA view* the mdanca for fiber type differential* in masothaltama risk a* inceneluaiv*. Among iha variable* that lnfiutaca tha sppesnr.es of maaethelioma ere length of obeenotion, duration af exposure, fiber cancantretioo. ud age dtstroution. Hence, studio* af worker* with cumulativ* axpaaore* eioaa ta or below it la pouibla that tusoihehom* ntk may ba higher from txpoture to fintr 100 f/ec-ytar* provide somo svidene* ef fibers, and that aparattona using risk bom working lifottOM exposum to OSHA'* PEL Studies finding advarte pulmonary tffaeta or ixoresiva mortality from lung diaaaaa from expaaun dsaa ta or below too f/ee-yeare wart conductad by Derry o( *L McDonald at aocidelii* may land to break fibers apart ta areka them am carcinogenic. Studio* In laboratory animals hive net eaoaiiientiy abearvod differential nsk by fiber type with regard to induction of pulmonary fibrosis *#d esneert: m fart, aL Qcmaat at al. Barry and Newhouse, soma ttudiaa in animal* have found and Finkalatatn. Oemam at aL Fiiktistrifl. and Htnderton and chrytatil* ta be ih meat exronotcnic among the venous tsbestss fibers EalctUe* alto ebrervtd axes** mortality lestad. DUP 0907251 JC075C DU 028352 51122 4Fedunil Rignter / Vol, ft. 1jjj / frn< .iv Nnv Lurs 'jncpr is ihr tushw nmy of V- Quantitative bisk Analysis S. Doxe-IXcrpunt* Model >ur Lunt ai0eiiis-4*.inteil oerupatinn.ii mortality. The very hth nsk of lung -t UttetnJuuiivn cancer from exposure lo .ill jvbrsti* fber tvpes support* ehwwtng tho unit PF1 for all fiber type*. | As *xpluinrd above. OSKA'i determination that eurrmity exposed workers face a grsve risk of .ubrsios. Srveral rpidcmielofie studies, related dtiesi* n primarily based on the ficiuii.ng one performed by N10S1U results of qmntiuttvg risk assessment have found that worker* exposed to tale performed by the Agency. The process containing a.betto* have exeat* of assessing the risk tram asbestos mortality from lung cancer and non- exposure meludcs several steps. OSHA maiigent respiratory disease. .Vlasy hai critically evaluated the scientific other ttudia* have observtd t.ttcii evidence concerning thu health risk from morbidity from reipiratory ditetshl ehaat X-ray abnormalities. and lung asbestos txposun. OSHA. * well as ether scientific groups, believes that function dccmmtnti among tueh workers. On* non-poattfva study conducted by SitUo and Tsborshsw o< tele worker* ha* methodoJogie limitation* aueb that it dooa not r*futa itudta* finding excess mortality among worker* exposed to talc esniaining asbestos. A numbar of itudiet in laboratory animal* hava impiicatad long thin aibotte* fibers in the etiology of anew and lung fibroids. Stanton at *L found (hot fibers gTtatcr man 4 win in fenyth and t.SismorlewIn diamotuf wero the most carcinogenic bowtvar. OSHA believe* that Stanton at af.'t atudie* do not axeiudk the possibility of asbestos exposure causes lung disease, respiratory eeaear. mesouieiioms. and gastrointestinal eancar. CSHA ha* also exsmmed (and discujifd la tha section astttlod Epidemiologic Evidtnct an Halt from Export/m or Current the PEL Section IV B.| evidence that indicates that excess disease risk ha* been observed at cumulative exposures at or below those permitted by the existing OSHA g-hour permissible exposure limit, in addition. OSifA hat made rtsk estimates of exeats morality from lung cancer, meiotheli mo. gaitroinnaanel eanetr and iaadanci of asbostesit using mathematical model* that deaenb* the data observed in epidemiologic studies * eonductad in virions indtutnai Cuncer Oo*-reponse information for lurtx euttetr based on the pidutnioio2tc.ii studies indicate* that the nik uf *besio-indue*d lung eonctr Increases Imeariy with duss:. Therefore. 0S1IA belies et it is appropriate to use a mathanutieai raudal which assumes thnt the exesss nsk is linearly proponionai to dais to estimate the excess mortality which is associated with asbestos exposure. This *xe** nsk is axprussad as the numbar of additional lung cancer deaths per fOOO workers exposed for specific time period. Excess nsk equals the cumulative, dot* multiplied by i potency coeffieiem (skip* of the dose* response curve) estimated from the studies. (Notr Total dose, also referred to it esmulativ* exposure or cumulative das*, is a measure of the amount of asbestos inhaled; it I* the product ef the duration of ixpeaurt (m years) and the intontity sf exposure (which it workplan air concentration in mppcf or fiben/ce). Under this difinitien of txpotur*. a person sxposed to airborne iibcatoa tt 2 fibers/cc for SO year* (so fibr*/ec-yers) bis tho same total dot* at a person who is txpesad to osbestos at 4 fibors/cc for to yn (40 fibers/cc- earetnog*nfeity of fibers shorter or thicker then that* dimension*. At Itaat 12 stadlea have observed eseast mortality from gastrointestinal cancer (stomach, esophagus, colon and populations. la meny rase* the titrated rlrka teen in worker poptiiabont reflect past exposurtt that were higher the* those permitted today. OSHA's quantitative Evidence of the linear deee-reipoai* relationship for lung ca*eat is found in tcvtral w*U-conductod rpidimislogic studies that examined lung eanesr mortality in relation to tha cuauiative roctum) sotoo; asbestos exposed workers. 7 or which found statistically risk assessment entails using the atbestea exposure in tb* workplace (for directly observed risks from these past exampi*. Hendarsoo sad Interim*. 1U79. significant extents. Other cancer sites exposures to estimate risk et lower Ex. *4-4*: Uddtll at L 1977. Ex. IS-SS: have also been observed to be inenaaed exposure level*. OSHA believe* this it a and Dement at ak. itlb Ex. *4-K). In by differed investigators OSHA scientifically apt .pnate ted valid believes that the positive human studies procedure. In toe* instances. OSHA the thrs* studies cited tliove. workplies sb4ai3i air eonetnirttions war* finding gastrointestinal cancer excesses estimated risks using ttudia* which avaiisbla from maaauramanu mad* in outweigh the non-posittva and equivocal actually observerrisks at or balow (ho worksite studied. Although the animal studio* of iagntad asbasin*, at cumulative exposure* permitted by tha siuiiles differ m the magnitude of the well aa the nae-p-0SJliv human studies. current standard. Tha rang* of studies nsk fouad (diacusaed later in the Tharefor*. OSHA conclude* that excess cover* many different work situations Motion), all thro# dtmenstratt a linear mom slity from gesmimeanaal cancer and txpotur* lavsia upon which to base rtlauanship tve the amir* rang* of should be included is qtiaatiiaifvo risk tb* tMrupoiatioa*. Where pasadai*. ebsarvaiion. amilt its for salsntoa- OSHA has quantified the rsnpet of Other soamisti and sctamific group* Qgnrette smoko and asbestos have a unecrtemhtt in tho estimate*. The** who have attamptsd to tsumate nsk multipiieatis* ityndrgtaUct (lfct with numerical estimate*, si well a* those v from aabasto* exposure here used the regard to prodacuaa of tang cancer. Asiicaieeit also aUpht bo inerteerd fa cigarette smoking a*bate** weriaro relative la non Masking asbestos worker* OSHA (a tot aware of any evidence for M effect sf dgnrottn amaking an twdwckoo of awMtheftamei or gnstremrefiinoi audignsneir* argnrrg usiirsms workers. Hammond el ei. found that bnth smoking and non* smuking aslmtu* tnsuiulMHi wurkrra ttud rvlutiv* risks for tunq ontW of ulwut 5. risk* observed et law txpetare*. were evaluated to detenume the significance of the risk and to determine whether the standard wlU lead to a aubauatial reduction m risk. The seutinna balow provide a brief synopsis of OSI lA's qoantit.niv* nsk caiimuirs Strived from mathematical models. A mnru detailed dvteriptinn uf OSt lA's calculation* for naheema* rolufi-d uuneiw* is in the public ducket * tftd m ividiiijlfW v(M(i (F.fc* ii. linear mod*! for tuft* cancer I Crump. Ex. U-C. British Advisory Committee on Asbestos. Ex. *0>21. Aeheton end Cardtwr. Ex. M-243. SebkofC Ex. U-l EPA. Ex. *4-110. CHAP. Ex- *4-2! The msdul is gmentlW secepitd and OSI IA believe* tie* of the linear model for predtam* km* caneer due to asbestos exposure is rousonabl* end wall, supported. Relative risk is defined us th rutiu of the mortuKty rate of exposed pi-rsuns io the mom*Illy rote of euoivxirnt non- DUP 0907252 J OC 73 ' DU 028353 federal Royster / Vol. <g. No. :u / Friday. N'ovtwbcf < 1083 I Rules and Rctul.mans exposed person*. Reletiv* risk is frequently ipproximatvii by the stinbsrdiztd mortslity rstia (SMR1. which is th* observed number of d<isihs in the txpoitd popuiafcn divided by th* numbsr of dssiht tpat would b sxp*eted m the ssposed population. Th number of tipected deaths ts usuuily derived from tne specific apt. sex. and calendar year mortality rates in th* comparison population. Based epon th* considerations ntted above and on the data, tha relative risk mode! used by 05! (A in sssussinp in* nsk of developini lun* cancer from osbtstee exposure is desenoed by thq following equation! \ **t C> iku * dt.i(j)J l.I| That Is, ner* I"* * *1 * f * *l-IO lt*' Is tn Wnp esneee aortal tty resulting fra* tne natitat asposure, j Is tnc siHctn aortal tty m tn aesanco of eiaoture, f ts tn* tnttnttty of asposure tn ftears/ee. o ts tna owratien of easosvr* tn years, t Is the Lta* from tne onset of ute eiatstet exposure in years tatm,s iCi years toeliaa for * outlaw* latent perioe) tn* *t ts tn* proportionality constant tost is e Mature of cm earctnaptntc poWncy of tn* tssettat exposure (tleo* ef the sos#*rtspus* curve;, (for t Mrt sets! 1*0 rttiensi* for tn* choice of tuts moooi, tee s. M-Jlf). Tnls calculation *s perforate for tea ftv*-y**r eg* inters*I; tne evereil lung center rra it cno* tiMutso u tM suet ef tM risks to eten of tut (l*y*sr inters*Is fre* ape 2S to ape 70. no concept of direct proportionality ef tbo nak of lu.i* cam... to the das* can be demonstrated with * simple exempt*. Utinp Equation i if den is inerttsed by * factor of three, tech ts uienatiflg tb* duration of exposure from two yean to six year*, (he excess relative niek ((KJ Rt)- l| nsk inert**** by * factor of dim. Alt*. reducing doe* by rtdudnp ir eoneemrjtion*. such as frma a fibml ce to 1 fiber/ec redoes* th* sxcasa relttivt nsk by factor of tour, (it should b* noted that the ttusutc* ol risk piveo la Tables 10 sad It era estimate* afexcess rwfc oof excess misuse risk. Therelater, direct ptetporaaulity *f do** and nak a* described ebav* amy nor bu ebetnrad. rnbtr expiate*** ts ptvea ia Sectiaa D C Com Aoapmuo US*M for Metothehnno OS! IA bt'ltrve* tiul lb* nek of metoibcliurau is beef reuuwtud by an abtolut* nek medeL Absolut* risk it among a cohort oi factory worker* in calculated as (observe. ieathc/penon- England. Limited dew -re also available yean at nak). Ut* of SMK's or relative from three studies an th* dose-response nsk is net appropriate for mesctheliom* relationship for mesothelioma (Setdman because the axpeettd number of daaths at aL t. Ex. M~7: Hobbs, at al. ltd is a cohort would be doit to tan dot to Ex. US, and fooea at ai. 19*0. Ex. * the rarity of the fbntt la oddities to 1J9). using abeolut* risk rathtr then relative Th* date Indicate that mortality from risk, tbia modal ia different {ram that mesothelioma begin* to incrces* only used fas lung casern because befit after a mmiatum of ten ytars following duration ef umt atace Initial exposure and duration of axpoaura are lb* initial exposure and begins to decrease after as years from enatt of determinative risk. Tbo magnitude ofthe., xposur* ISpllkoff at aU 1179. Ex. 9*90 risk bierease* linearly with intenaity of exposure. whereas tha risk increase* exponentially with dumtiea of axposare and Nicholson at ai. 1913. Ex. M-Ul). Th* mortality from mesothelioma can be described by tha followup equations and time from entet af axpoev*. Tb* ntioewl* for such * medei fur (EgutdsaslL describing mesothelioma risk baa been discussed by eevtrui authors (Anulago and OulLTSM. lx. aa-iSS Pike iPod. Kx. M-1IS). Ouch a modal wat uubaad by Newhuuau und Berry (197*. Ex. M-WJ) bi predicting mosotheiiama mortality OOP 0907253 J0G722 DU 028354 IWZi Federi Register ' Vol. ta. No. 21j / fnc*y. novc-tvoct ,. *V * t th \k\l . (0fJ - {t*(Q.4|J] f * S ^*0)* i*v4 far t !JN 'or Ias>tfcl0 for I0> t It tM aartellt/ fran asset**I tana. f It tn* lmtMtt/ af UMtvrt tn ft6*rt/ee, t it tea auritten #f i***ur* la jrttrt, t It tm* sf tar firtt uaoturs tn jeers, <M ** it tn# areaert tensing constant tnat it a aetture at tM aeautnuito** carciaatantc actsncr (iloae a' a **M-'s*4*tt eurvt) (Cs. 64-2*2/. D. OSHA '$ Quttitieaavt Aitk Asttuaunt OSHA'i critical evalusiioa of all rtlavant animal and apidtmiolagieai itudiaa resulted In selection of alavan epidemiological studies (or eeicoietion of ilia ICt far lung eenear (Salikoff at aL 1679, Ex. aa-Kt Stidmaa at aL 2979. La. #4-47: Henderson and Enttriina. 1179. Ex. 94-4* Waill at iL 2979. Ex. 94-200: Flnk*l*t*ix-ll9J. h 94-2401 Pat*. 1910. Is. #4299t Dement at aL 1992.Ex. *39: Barry and Newhouse. 1993. lx. 94-22; Liddall at aL 1977. Ex. tt-U: Nicholson at ai. 1979 Ex. 94-72: and Rubiao at aL tin. Ex. 14-91] and four for K for masotkaliom* (Salikoff at aL 1979. Ex. a*-ao-. Saidman a*, ai. 2179. Ex. *a-*7: Pinkalataia at. aL 2992. Ex. *Mft and Pato. 1990. Ex 94-169). In itnaraL atudiaa o( human cohorts m 'He workplace ahouid provide a batter lima for quaautauvt nik populations at nak and the papulations (rein which the nak estimates are derived. In detamtinini the potency coefficient! and K* Equations l and 1 ware used t* delta* the dose-mspassa reiaiionahip a* that cancer mortality was tttimated for various exposure lavait and exposure durations. A number of watt*coridueiad and hijh euahty aptdamMopic atudiaa wart available that esatainmfaafllcfant information on which to base a eaantitativa risk aasaatmant. Soma al these ttudiea did tat etetti* axpoture dale, but could be coupled with exposure fefarmetim Crem athar aaurea* hi order to ahum * aatimata ef Kt and K OW tA ckaea net t* aaa animal atudiaa to predict quenUutttv* eennutra ef risk from asbettoa exposure due to the many high quality human atudie* Uuil exist ihui were eondueted in actual ' workplace situations. Rather OftIA Sue uppiamtntcd the human data with results (ram animal atudiaa In ths valuation ef the health tnfsrmatian and la the datsrmtnation ef the utmilcane* of risk bacauta OSHA believes that the animal studies provide valuable qualitative information on asbestos* related disease. U la not dear in all instsnest whether laboratory arutnala have been exposed to fiber list distributions similar ta those found in workpiece*. In addition, asbestos appear* ta multiply the underlying lung cancer nak ef smeicmi and nonsmoking workers: laboratory enimela tcnerelly da not have any underlying risk for developing lung cancer. However, the tatmal studita do chow that all cantatateial sabaataa type* can cause caneer and pulmonary fibrosis. Animal studies alaa indicate that longer, thinner fiber* may bavt greater carcinogenic potency than short coaria fibers. The rang* of estimates of risk from the eleven epidemiologic studies ta rather large. The differences in results among the atudie* can bt explained in several way*. Thar* appear* ta be actual difference* in nrk depending upon tha nature of ths asbestos exposure. On* potential explanation it that workpiaeae differ with regard to Tiber snta diatnbetietu (longer Hoar fiber* appear to have graatar carcinogenic potential the* th* eaarte fibers). The observed K. value* for itttdtaa ef mining and milling operation*, where airborne fibers are relativaiy eosrte. are lower then th* K* value* found in atudiaa of textile operation* where fibers are fin*. DifTafanca* may also be explained by th* variation* In study dasien and ether factors influencing th* ability to date axesas risks. On* ef thas* i* th* iimitad knowledge of putt fiber txpnaura* of thaa* population* whoa* mortuiity was later evuluaiad. Prior to taro, few measurements wrrt mad* m fsethties using obestos fiber*. Furthar. those measurement* that wart dona usually queniifisd all dual prtsant m tha workplace air and not juit fiber*. Current itebniquat. which involve us* qf mambrana fillers and phase centresi microscopy for ih* counting ef fiber* longer than five mieromettrt have bean utilised la Crest Britain and th* United Siatea only Knee 1*84 (Aytr at at. 19G3. Ex. 94-213:) and have bats standardised la tha United Suite* enly since ip?j (Uidei. 197*. Ex. 94-421 and avtn later la Great Intern, ta any cat*, samplmt he* occurred only for ftw worksites and thaa only occasionally. OSHA has evaluated that* differences and have dealt with their implication* an a study by study basis, at expiaintd in th* quantitative risk etaaumtnt (Ex. *4- . 392). OSHA Bolts thet despite these apparent limitations. taken ea * whole, th* aebeeto* atudie* contain data of unusually high quality which hat enabled OSHA to mekt th* nak aatimata* with a high dagra* af confidence. tn addition, variability in work aettvitiet and in sampling etreussunces add considerable uncarteinry to kaowladgt of date. Some of the epidemiologic ttudiea. Including those by Ocatnt at aL (Ex. 943SL MeSeneld at aL (Ex. 94-44). end Henderson and EntariJaa (Ex. 94-49). have maaawad air concentrations at the exposure site and died job histenet of th* study population to estimate axpoaur*. in thaa* oasis th* dataresponse curve w*t calcuiatad by animating Intel asbestos axpoaur* (in atppcf.yaar* a* in fib*r/eeyar-) according t* th* tima that tn individual spent at a (ob with a measured exposure value. A conversion factor for esnvarting bees xippei to 1/ec was employed on c study by study basis depending span the date available. Outer epidemiological stadias, for axampi* these by Salikoff at el. (Ex. 9490). and Saidman at sL (Ex. 94-671. had neither |ob histories nor direct industrial jtygien* meeaarements for th* studied worker population. For dies* snidus, axpoaur* aattmataa ware dcnvtd from Industrial hygiene surveys of similar work sparsuont nd practsias (or which industrial hygiaaa data war* available. Tha study by Saidman at *1. however, contained |eod information regarding duration af axpatur* (which een slum b* examined at t turroeutt for data in establishing the thapt of (he axpeaure-eeapoeta relationship). A di.euwd in Section IV. OSHA ht concluded that workers expoacu to DUP 0907254 C C 733 DU 028355 iCTyWPWHa ^WilBilliW^i^gaaBiTiiwg^iMgfaasar Ftdcf<l Regular / V0|, 41 Nn r_j f frirfiy, November 4. 1963 I Ruins end R^lai'.or-.i 51U5 itipcnoj rt likly to be at in increned or in lomo cam. itatiaticai aljuifjniwmuiurul aiiaf. Thaiffi* uncertaintiai anoctaiad with imafl irithmotic md fiometne manni of their rattoi are 1X10"*. Thui. txio* nan in excist otCI uncer htinot boa* _ number*. Oitatiad derivation of taeh ippfnpnit* ehotet n thi bait ntimita oTttrvrd eonuitemly InTvtry*ifu'dy of rengt of uncertainty it dimmed in Ex. of Xs/Kt. Uii(i| this astimaia of tha rmo iioestoa wqrkerfctnd whili tht ruio of U-M2. Xa/K^ind tit* prafarrtd animate of Xi. i<Hiainitiiin'Lsinc4~iolun conciF Tht diitinct nature of mining*mitling (021|. tht preferred tstunitt of Ka ' yjji coandireblr Imm itudyjtojtudy. dtta (and bine*. lha retimatss of would b* lxt0*(XutxI0',, then ippeir* to ba-a^iGciant tyidcace from thaio data) have bam considered X1 x 10**). A ranft of 1 x 10" to 3 x io*' to roughly retime to the iaii tariier. Thin n ion* ividanca that tor Ko would appropriately repmant iiiercmtiitinal eoneif nilTin isbestot. niki in tin iibaatat atinuig-fliiiiing naoiw pcpuii lions. l i*n*rllHht'*HIfc apireaon* ira tower than othar aoit exposure ittuiaon*. There la no avidane* in (hit inalyiii renin frea iboui 5 Idl&lJTJhi'ixani Hint caocreriik. fA deUiled tofali flUhe nk from taitrofmeitinel cancer otiirviytfl'g Kudus iijivpn iiTEx. ** 992). la la'titempt to quantify thi tuk of Induitnal oparettotu due to di/fermere In Obtr ma. Thu*. to dattmining tha bait avareU value far K, from the alavan ituditi. the data ware txamintd both with and without tha K<. calcuiatad from that would u*it tin: < ipaciii Jung canear potency fa ucribabl* to a pacific type at Cbar. Semi of th* bightit and towtst vsiuti tor X). art obtalnad from pure chryaotil* txpoiurat giitreintsirtnai eaneir. OSHA consider* tha itudiaa af minuti-nullitii prsciisas. (far example. Kt eeiculatad from Pita of that a iimpi* nik modal in which tho The renf* af individual vaiuat far Dtmant at al i* 0242: atuig data from lunt eaacar txctn to multiplied by 0.1 eavm twa ardara af magnitude. from Pate at ti givai a K, of 02070). (10*) la ipprepnata for reheating the 02001 ta 096!. Tha arithmetic mean ef Kxpoauret invoivtng o mixmre of flbert. nik from gistrointretmii etnear. Tho aatimatu of risk from giitremttsunil tha eleven value* el K. (unit riak par f-y/ Indading ammito and eroddolito. ilio ee) is OLOSOl. and 00207 whan the Kc'a span a large rang* ef vahoai tor KL. .canear am alia giv to Tibire 10 and 11 Caneno at litai othar than tho tong, mnothsiltun. and gutromtiiunal tract have boon ihown m bo ilavatad in toma aabaitoi ixpoiure awdiao. kidudiag IiryngtiL Udnay. pharyngeal and buccal cavity caocar. Ta OSHA. it appaara that tha axeaaa nik for "other eaacam* it about tha tama u far gasmuMaitlesi cancan. OSHA racotniaaa many uncartaintiaa in quantify*! tfaia risk. in viaw of tha iaeasautcnciaa In findings meat dUTaraat epidemiologic itudiaa. (Soma itudiaa have found axeaaa riik from othar eancan. whila other itudiaa have not.) Tha litea ihowing tactn risk have ataa vahad amanq itudiaa. Therefore. OSHA hat net made nummeat aatimataa of mke for then other cauaei at thia time. The data Indicating inirointutinil cancer axcaaaaa are itronqir and more eoniutint than tha data luggtiting excess at thaio othar caocar utai. OSHA doaa aet faai eompiUad to quantify thta nik at thii Ume. Tha hi|h quality and wait* tupportid minutes of aacau nik el mortality from tuna aaocar. Miothalioma and aaheataiie ataao provide tuffidant tuaaa upon which to fuattfy tin action. from rninini aad mtiUnf are axciudad. Wide diffarenca* alio occur in-th* Tha faomatne naan af tha data la 0207; multi af isparata apidamioiogtcel whan the attuneta* of K* from muting- hmUm oflimiiar w*rk oonditioai. milling oparauan* are *xciuda& tha tore# scientists have loggsatid that taaaatna naan af the Xv`i fa 02111. Tho ism* asbaatoi precatu*. lueh at Kt'i kav* a mtdiaa af noohi with tho nbattaa MxtUt aunufaerurfng. may mining-nulling proem <* and a median pcMigreatar hataxd than other el 02131 whan the tuning-milling procaMoa. For aximpii. mining and peace**** era excluded. Coniidenni tht Industrial procaaaas othar than atining end etlQlrtf. OSHA boiievte 021 ta bo raeanaable estimate efK), Ilia tha geometric mean end medial *f the lO derived fram milling appears ta pots a Uttar caictoeganic heura than manufacturing Mocasaa*. OSHA coopered tha potency factor* far lung eaacar (KJ among difftreat spidraietogy itudiaa af manuficturing pracauaa bacauio th* ' itudiaa af aabeatos auaafaeiurinaand iaeuietfoA application proesaaa*. The t* xnttne atan bet th* advaatai* of potency factor* are band on riik p*r anil dare. No eonifatant patttm of dilferatial lung canear mk (i.a. higher madadsna th* fnfluanae af auUyint K s) by preceta aaargad. On* study of value* ana eK^et 0211* appraximataly 4h**t** tixtil* worker* found e very within ana order of msimtuda of ail the high nik while another found i much aatuaataa of K^. ta ran1, th* K| of 021 is tower tuk. aad tha taaw was Tut for a heat tiumiii which eontains tha twa ituditi ef aabaitei production appropriet* recotmtioa ef atudiai with workers tad tho two studio* of tsbtsto* hi|h*r and lower value* of Xv It thould lament workart. TTitnfer*. iht ehoic* of bo aotad howavaa that the ancarteintia* a atidpoint anit risk far all industrial amad thi* attireata af X. are tueh that precastii (Kia0211 it * reasonabli md an aporopnatt aatimett of Kfc emid U# (astifiad ehoic*. botwaaw 0203 end 023. Th* boat aatimataa af Kv and XH were Tho animat*! *i K given in Table 13. utlltoad t* aatiauti th* morielity from are dahvod fra* itudiaa with four of tho expoiarea to varying eaneantrstione of Bva hiqhcat Kt voluao. That t*. there ia oahettoo for difforant time period* Man bias hi niniMi tha vaiuo af Ka beginning at different igea. Th* Indepandant of tho X* in tha Mm* , calculations are ag*. inianaity md Cilietetet of Caiirer Nmelity nudita baeausa it ia likely that thaaa Ka duntion tpacific. Tibiat to ind it show A boat rtuoMta of K( waa calcuiatad would tend to b* illfhtiy hi|har then tht axetu asbatiawreiatad mcnilny for each of tha atrvaw Hhdrmiologic thooe dartvad fratn othar studio*, dua to retos from lung canear. autsothationu. itudiaa aad an ratonate of Ka waa th* dtmoaitretod high power af thaaa and goiuoimiitinai canear calculated from bur af thata itudiaa itudiaa to detect nik. Tha antkmetia (gaitremtaatinai eaxeer txceu n (aaa Table | IKv M>33S. For each main af tht Ka'i ia aJdxiO**. and th* aiauaiad i* b* >0 percent ef the lung study, tha beat eatuoute fur Kt and Ka la loctnatric mean ef th* Ka'i la 191 xio**. eancar oxeau). in three catoutoiiom. Indtcatml akma with a tuner ef T* aceauiu for aoma af thi* bit* whan Equatton 1 and Equation 3 wore used uncertainty. The runur* luted ant thuie aattmatinf K*. it la ureful to txaaim tht with vuluas *f Ki equal to 0.01 and K, are the malt uf of r\(Kiure ratio ef Ka tu Kt. For the four itudiot tor quo] l# 1X10-' and the 1977 U.S. mete uncertuintMi (uu.ilU a furt.ir of 11. which Ka waa calcuiatad. th* rang* af beekgreuod hmg eanctr mortality RIOthiHliiUica <<i "e. I..<>(w*m 1h*t lint to the ruik>s af Ka to X*. I* only two-foid Booawea of oge-ipeetiic mereaie* in tunp alternuti' t-v.iiuuiMHia uf ink of vxpmure (from 0-7$ x to** to Ut x 10**). Both tho caocar rates in elder men unco 1977. DUP 0907255 J r\ p 7 7 * Jd / - DU 028356 5112S Fedoral Rcsiflff / Vol. 4R. No. 2u / Kridtiv, November 4, lira I Rules snd Regulations estimates lined an mure recent background ruti-a would lx* higher. Calculations were done for such 1-yaar age interval, and then summed to give a total lifetime nsk. The eulcilaiions purfurmed to give the resvls in Tables 10 and n illumed that the relative ruk trereaMd following tea ysbra after onset of exposure and continued to nee until ten year* after staution of txpoturt. after which it renamed tamtam. Table 10 (fvea eiUmeie* of nek for one year of exposure to asbestos et venous eonetntrationi for workers beginning exposure et agea 2& 30. 40. U end SO. It ahouid be noted thst employees exposed et lerlier ign show higher nak of ill eenr.era duo to tho long parted of lime during which it will be pouible for diieete to develop. Ono veer of exposure to asbestos at 2 f/cc ttaruag at age u may raatdt in a total axcesa eanctf nik of 341 par 100.900 workers. Table U give* the predicted excess lifetlma risk of esnetr for exposures of one year. 20 years, and 49 years assuming first exposure st toe 29. Sevtral caxunanu should be made regarding the resulta In Tables 10 and ~ ll. Though axeeaa rolauve risk is linear in doss, the excels mortality rates givt* in Tubtss 10 end 11 art not itriedy linear in doaa. Therefore. Car seamsla, the nak at 2 f/cc is sot meetly I tinea (he risk at 0.9 [fee. though thert ia a dots approx.flwtion. it should uito be notad that the nska for longer periods of exposures do not appear to be a straight-forward multiplication of th risks of shorter duration. In (ha longer exposures categories, whan txposure will affect older workers, tome adjustments have been made for competing naka which are likely to affect the death rata from lung eaaeer. In addition, whan looking at tha total eancar neks. It must be rsmambarad that theta Include the risk of matoiktUoma. which ia related to tuno ia an exponential fashion. A* can ba seen bora Table 11. the pradimec ik from matotheiioana is approttr.utaiy equal to the lung cancer risk tor sat year of exposure and. about nnvhalf the risk value for king eaacsr in '-> 20-yssr exposure group. Tha axcesa risk of menothelioma after a lifetime txposure (as yaara) to asbestos is approximately one-third tho bfstimt sxesax lung cancer nak. These predictions comport with tbtervetiera la severs! populations, whore mortality from mesothelioma is observed to cocaprise approximately SO pereeat of tho axcast mortality from lun; cancer. Using tha iguauons givsa tariiar. and baaed an tho calculations la Table 11. OSKA pradieti a lifatlma axcoaa risk al total cancer tor a lifetime exposure (45 years) to X f/cc is Mil txcati deaths per lflOPOO workers, or spproxinutety os per IdOU. Recognizing that a CO year rxposurs lo asbestos may b another approximation of actual worker , experience of inlarnt. the models predict an axena cancer mortality of 092 deaths pdf tOCJJOO workers. Reduction In tho PEL from 2 f/cc to 3-5 f/cc reduces tho risk from lifatlma exposure from Od per 1.000 to 12 per 1.000. Similarly, for a 20 yaar exposure, tha risk ia reduced from 44 par 1.000. to 11 per 1.000. representing a /l* reduction in nak. The lifetime risk from sue yaar of xsoeura fellows a similar estate. The risk reduces boa 2M per 10X000 at 21/ ee. to 2d par 100000 at 0.9 f/cc. Aa discussed above, this implies that tha lifatlma sxesss nak from a sixmonth exposure to asbailee would be approximately 1*1 par lOOJOO at 2 (fee. and 22 per 100.000 at 09 dec. Lastly. Table 11 contains tha risks for levels higher than 2 f/cc. because OSHA believes some industrial areas (such as construction! may bo at there higher levels. This population of wotktrt would consequently experience a much greater reduction ht nak by exposures to as dec. or fats. WMIM SIMM I DU? 0907256 JI n'J fUi "I - 028357 Federii Router I Vol. g. }0. j. j / Suvumucr 4. ism / Ru/t-Jt .mil Rr*n(.it T0I* Estimates of tne Slope Parameter* for tun? Cancer ^ ana Mesotntltoma 4**;, 0/ Process 3n:r Study f WANUfACTuRiefi r*L -1/ S^stO* Asbestos Products Henderson 4 Enterline (1979) 0.0047 (0.002b - 0.00*4) Asbestos Cement Products Mill et al. (1979) Ffnkeistein (1983) 0.0033 (0.0016 - 0.0086) 0.067 (0.033 - 0.13) 12 (4-30) Textile Products Peto (l980) 0.0076 (0.0009 - 0.023) 0.7 (0.3-2; Oemnt et al. (l982) .042 (0.023 0.21) Friction Products fcerry 4 Neunouse (1983) O.OQCd lO 0.008) Insulation Products t Seidaan et a). (1979) 0.068 (0.0049 0.14) 5.7 (3-11) INSULATION APPLICATION ielUoff et al. (1979) 0.020 (0.008 - 0.030) l.S (0.9 - 2.5) MINlNfi>M!U.lhG Udceli et al. (1977) Nicholson et al. (1979) Rubtno et al. (1979) 0.00066 (0.0002 - 0.0011) 0.0023 (0.001 0.007) 0.0061 (0 - 0.009) 1 Values in parentheses represent the ranee of uncertainty arouno tne estimates of K end K. These art cMputeo on a stuty py study oasis ane calculations for aacn study are discussed in tne test. ' S'Siii6l . 1.79 0.92 m 0.84 .75 <T\ DTJP 0907257 DU 028358 sun Federal Rcijiilcr / Vol. 4fl, No. 21J / Fnd.iy. November < ' Rules and Regu.ui-um Table 10 Estimated asbestos relates cancer mortality from on* /ear exposure is various (icer concentric sns -j Ashettat flbor ' concentration (f/U Cancer mortality /100.000 exposed n*otn- . t-un$ liooa uastromtestmai1 Total Age >t first exposure: 20 O.l 7.2 9.S .7 0.2 O.S 14.3 19.9 3S.8 47.3 1.4 3.6 2.0 142,ft 130.7 14.3 16.2 34.6 86.7 34S.3 Ag* at first exposure: 30 O.l 7.3 4.9 .7 0.2 14.S 9.a 1.4 0.6 30.3 24.4 3.6 2.0 144.9 97.4 14.S 12.9 25.7 64.3 266.6 *94 It first exposure: 40 O.l 0.2 7.1 2.1 14.1 4.3 .7 1.4 O.S 3S.3 10.7 3.5 2.0 * 140.9 42.6 14.1 *.9 19.0 49.S 197.6 *gt at first exposure 50 O.l 6.1 0.7 .6 0.2 12.2 i.S 1.2 O.S 30.4 3.7 S 3.0 2.0 121.7 14.7 12.2 7.4 14.9 37.0 140.6 O.l 0.2 ' O.S 2.0 Ag* *t first ixoosur* : 60 4.0 0.2 ft.O 0.3 19.9 0.9 79.0 3.4 .4 .0 2.0 6.0 4.1 * 9.1 ZZeA 91.0 T' ittiutM iTlO* of lung cnc*r risk r*tner than calculated uotng tfos**rtS0ons* inform*non. UP 090725a J00 7 DU 028359 fcrai **vM#r / voi. . no .iia / rru-iy Table U cmucr * , r.. * - Estimated Asbestos Belated Cancer nortal'ty per 100,000 PvtvHuriotr of Tears Exuosea ana Exposure level* Asbestos fiber concentration if/D 0.1 0.2 o.s 2.0 <.0 0/. 0.2 O.S 2.0 4.0 5.0 10.0 0.1 0.2 0.' 2.0 4.0 5.0 10.0 Cancer mortality /ICO.OOP exposed Lung Mena Gastrointestinal* Total 1 year exposure 7.2 6.9 14.4 13.8 36.1 34.6 144 138 288 275 360 344 715 684 0.7 1.4 3.6 14.4 28.6 36.0 71.5 20 year exposure 139 278 692 2713 5278 6509 12177 231 460 1143 4416 8441 10318 18515 73 13.9 146 27.8 362 69.2 1408 271.3 2706 .527.8 3317 650.9 6024 1217.7 45 years exposure 82 23.1 164 46.0 407 114.3 1554 441.6 2924 ,844.1 3547 1031.8 6141 1851.5 14.8 29.6 74 *3 591.8 740.0 1470.5 225.9 451.8 1123.2 4392.3 8511.8 10476.9 13996.7 336.1 670.0 1664.3 6411.6 12209.1 14896.6 26507.S 1 Asju/ms exposure begins at age 2S. tsks are calculated using u.S nale lung cancer background rates for 1977. ,, 2 Estimated as 10% of lung cancer risk rather than calculated using dose*respdltsa information. DU? 0907259 JCG738 DU 028360 SI 130 0 4Federal Reamer I Vul 4ft. N 2*.S / Krid.iv Novrmnur . f Quantifying me E\Crt* fh*k from Aibettosis Many siudics have found the nonmaiignxnt iun| disease. ssiiestosis smong estitttot-axpctod workers. In feet, early occupational hkilth tundirdt govtrnmg nbreoi exposure pnmsniy roughi to reduc<the incidence of itbcstotis. Asbcstosis it type of puimansry fibrosis diagnosed on the bain of hmory of exposure to tibeitoc it l eharseterixad by radiologic dungei to the lung, breathlessness. impaired lung function, end other eliflicel fctturet of filmeinp lung disease. Asbestos!* eett be mtntfctted m e range of degrees of evenly end aortiuit in disability end death. An eeriy rtxpanie by the lung to asbestos exposure ti formation of plaques. which ere opequo petchee visible on ehtet X-rays. The pretence of pftqatt might Indicate increased riak of future development of asbestos!*. but thfe ie not certain. Although the dieeaM significance of pleural plaques ie not eiear. the preMoca of the plequet la not normal. * Berry at al. litre. Ex. W-20I define* *poMihia atbestotis" et a lunc ~ condition bated upon n*ns of taHy asbcstosis. He daittflet '>00111110 asbcstosis* oa the finding of basal rales or erepftatfooa. ndlologiul changes of vsiying dagrae. a failing |na trantfar factor, and restrictive enangti in lung volume or vtntiiatory capacity. The dtflnition of tabettotia veriet among dilTerant investigators. Berry et al.'t definition at peaaible asbcstosis. far aumple. is not auffielant for the vietim to quelify lor Oritiah Ditabiement Benefit. Atiieaioaii can progreta to a ditabling condition where active work it no longer potnula. Although no ample definition of diaabiUty axitti. vanoua governments have adopted definitions of stbeitot diubility to admintttar their worker'e compensation Iowa. Finkelstein explaina the lyitam atad by the Ontario Workman'! Compensation Board: Waricra tvbsiiltiaa elaime te ike Cavpvnuiian leant aso rxamiaail by Our Aiivnary Committee. utuch teenuneeda ar!*ihrr tr nan OaaWT hnw be tnmud. Thera am eo auwi antarta fca the awarding at a OisabUny Scasiea (ur sbesiasw. hw Mow at the Urn aunudaiud eictedee Malory ef "wtapsaie* samara. a tMery of dyeem. Ow anseacs at crrpiutuet or nxluieiMphic atpra et pulamuty fibraais ami ohmewal palmunarr funenoe imwits ti'. SS-M. p. 0*4. Asbntlons h.i been known to progress or wurten alter cessation of exposure. prulmlily due to irrmruitilu ln|ury and/ur the rntenfion of aibctiua fibers in the lung in sddmon to lung function impuirment. atU'itntit contributes to increased ssbestosrelated mertutity. Increased rvmurvcu created by the lung obstruction can lead to heart failure. Because of the mtny poutble definitions of eibtstosit given by difTarent grou^:. the qusotifieetiun of a ingle rtsk associated with asbcstosis is difficult It is clear that matartal impairment from asbestosta occurs prior to the onset of Its disabling stage. Qusntitativs studies exist, primarily for the disabling forma of the disease pacifically, two separate ttudiet provide information to develop a doom rsaponta relationship between asbestos enpesuri and incidence of tabeatosia (Ex. 14-20 and *4-44). Two definition* will be helpful in interpreting the dau canearning sibeitaiu. Incident* is the rate at which ntw euti of ubeatosia develop in 1 given period el time, it U a direct measure of the nk of developing the disease. On tba ether hand, prevalence measures the number of exact alive in e population at a given period of Unto. Numerically. It tquais tba sum of til the inddinea easaa in tht put minus all the deaths that have occurred la people who had developed the disease. Prevalence can be reflective of existing risk for atbtitesis m a population: prevalence however, can be high for ether reasons, such as increased survival. Moteaver. incidence tsubiishas a time sequence whereat prtvalsnei looks at both cause and affect siimiltap oualy- The beat estimates of risk of aibeaiotis have been euleuUited from incidence dui.i of two studies. Berry tnd Lewinsonn <F..v -2W| and Kinkrlstem (fit 4+-UL OSIIA hut also examined prevalence rate* to uppon a qusnmsuve sscssmrnt of risk fur sibattoi. and r these data wiU be discussed first. Berry tt aL (in Ex. **-! studied .1' group of 321 man who worked at an asbestos toxtiit factory for at least in years. Oust measurements wan vatlabfe and war* correlated to each fob performed for tech year under tudy. Health affacti ware consisted to cumulsttva exposure. Table 12 ihow the observed prtvalence of erapttationi. "possible asbcstosis". and certified tibestos for data from Bany at at. at taken from the fi.ted curve in Figure 4 of their paper. Possible aibettosis was diagnosed by the factory medical officer if ha thought that a man wet developing signs or symptoms of tarly aibestestr. SOU of the man diagnosed with possible asbestosta received certification within tht 34 years following this diagnosis. The results in Table 12 represent a group of workers tmploytd after UK. w ho bed a relatively abort duration of follow up (maximum interval bom first exposora was S3 ysarsl. A higher percentage of asbcstosis would moat likely heve been observed if the follow- up peried is tba study had bom xundsi. The observetiona of Berry it aL preeented in Table 12 are protoebiy undtrestimatte el risk. First, tht nsk shown is Table 12 does not give the probability of developing disease after sxpesure has ended but ratktr. reports the disease found et one point in umt. Second, tba data includas soma workers who may not hav* been followed Ion; aaough tor asbesiasu to appear. TUU 12 auvktKt V cataiTATiOhS. roistsu uwrosts axa ctarirtco Auaroili foe cimarivf upoums to aaauTOs raon uni t at. lit?*) Seresnt vice csnsittsn \' * 10- CtsMiatw* tseesurt. fllirfet . Kilt Craotutieet hettibia asastut is 12 *4 ti M M ut 100 1)4 ASldUl'l 43 too uo ia DUP 0907260 j)U 028361 T>*e d.a of fiery i ul. dimonstr.ue sever.i fcniurct of the* nature of the esbeitosis rtsx. Th data mow continuum uf clinical response mcr th* nn of dost*: tht it. the** dime*! observations support the \iionr* nf den-reipomt relwionship. Second, then observatin**lo support tht exutener of low. or pombly mi. ihrfjnotil fur *Listua>a. itnee there it increased nik at eumu/attv* txpoiurei at low ui jr fiber/eejeun. Derry end Lewmsonn (1J77 Ex. 14- ZJ4) have reported the incidence of sbestosre in this some itbettoi tot tile factory, Thaae data are pritumted ta Table 13, A dose-response rc*l.etion*ni|; it apparent for th* incidence d.iia, tint :t li not dutte at eontittem (or me prevalence dale. Taele 1} Inetdenee of Possible Ascescosts / Cams I stive Exposure terry and Levinson* Cusvlattve Exposure (ftBtr/ee-yeert) 0*41 50-99 100-141 tS0-il 200-241 300-349 \ i incidence first iploytn( Sefore list After 14W 0.4 21 2.6 2 3.9 6.2 4.8 Fiakelstsm (1941 b 8V44| looked at the development of eapsB*abie__ (certified) atbetteau among an'worker* at an asbestos-cement faetory in Ontario. A dose-response reJetionship wa developed using wttmittd eamslettue exposures baaad on plum duat measurements and using medical Information from the Ontana Workmen i Caanpeneotioa Board. Table Id ahowi the Inddence of certified ttbeetatu eaiea e e function of cumulative exposers fmm the FVtkefilein ttidy. TAIU 1 iNCIOCteCC Of CtRTIFIEO A58ESTGSIS AS A fUhCTIOh OF CUrtUUATlve EXFOSUU MtaCELSTIIh (1182) Ciaeultelve exposure floer-ye*r/ee 0-49 50-99 100-149 150-199 200-249 WA X Inetoence O.S 3.6 I.S 7.9 14.3 rinkelitein't (IMS) ebeenrattene may overetete the injudence of atbeitoils became et autopsy, there wee histologic evidence of silicosis s well at eabeitoeie in many men. FInknieteta etetce that "we hove, aevcrthelese. cheese to ted their dieooet ssbestosi*' at we behave that fe the pathofopto proeettt aC awn significance. Meet of the purrnckymai radiographic abnormalities were small Irrcsuiar opacities nnd the mortality pettum amona the men waa consistent with the teaie nffertt* of asbestos." On the other hand. Flnkelsuan's etudy may have , understated aebettoeis nak by examining only certified disability from sebceteeia. which is an advaaead ataga af aabeetoaia. OSliA't eeuaiatee of risk were derived from e aimpie linear recraesiun of tlic incidence on the midpoints or the cumulative exposure date of Berry end Lew inewiia (Table 13) and fmkeUteia (Table 14). A linear ruUtltunship wae uuumni. at leaft to ilia pmnt euttmation ofOSbbert/eeforadysers lor ZiS fiber yoere/ec). This suumpuon n eoniiitent with the (net that early eiegei of disease* ere observed at low exposures. A similar candustec is drawn in the report of the British Advisory Committo an Asbestos (Ex. $8-218. volume 2. ? 38|. "The present authors come down in fever of u dote response relationship without e threshold for ehrysotilt- wuhir tht renge experienced u> mduttry " DUP 0907261 JOC an *v DU 028362 51133 113Federal Regmer / Vol. 4B. No. ;;; / fr.djy. November 4. 13 / RU|M 8nd Rrgmaiior.s taili n fibcrs/ec (p. *). I la reduces this level tsrinATti 0f liftTlw ASttsiasu inciocKti by t factor of two to account for differences between persona 1 tnd static Cisosurt level, 1 Incidence sampling (p. tt). Thus. Crump's fi*r/ee 0.1 1 2 1 10 k l Fliutlsttin 1.24 l 2.41 4.1; 12.41 24.tt 1erry. first etoloyed: lefer* Hit After IVW o.u O.Ji O.H 8.H 1.71 l.tt 4.44 I.M I.IJ t.3 etumaies for a 2 fibar/ec standard will be four times lower than those estimate* : mad* by OSitA for average worker expesurt* of 2 fibar/ec. Such difference* in euumptiono should be kept in mind whso eompartn* risk etsossmentt by dlffenot authors (Crump s ettimats it 2 S'op* z 8.Mi 0 .Ml 0.029 .Ml 0.911 .M4 f/ee would bo compered ta OSHA s teamst* at Ot f/ee). OSHA hat presenttd the risk as if tits working population were exposed to an aver*|e Th* malts of taeh of Ut* regression anvtrenmant ta gtntrato quontitativ* conumntion of 2. 1. BJ and 0.1 fibers/ analyst* and predictions of incidence osumattt. Animal studies art utd to ee reflecting OSKA't belief that a forseveral dot* cor centracons trt only support and justify m*thodoio*ieaj standard ofl f/ee does net preclude given in Tobl* It Ai this list* OSHA procedures and assumptions worker expoeure tt that level: in fact mokos oo ttiimpt to axtrepolata th* dot* osii>| this mods! below th* 8J qualitatively: For lun* unear. seianttata exposure! may avast exceed 2 fibers/ce |ta*raily aeeapt tha linaar aiodai far short periods end still produce an * fib*r/ lovoi or abov* 10 fibtr/ec ImL rtlatin* ineraastd asbestos *xpe*ur to hour TWA below 2 f/ce. Th* ootimatot from th* S ceheru differ by *n approximate factor of 1 This may bo indicative of son* of th* risk and gtnerally teeapt th* lack of s threshold. At stated by tha Iritiah Advisory Cemmitta* an Aabretaa: "Far Th* report af th* British Advisory Commute* oa Asbestos contains on* of th* first quantitative nek assessments methodological Issue* raisad urtir. H la lun* unear. th* avaflabl* data is max. pessibl* that ih esUmsits mad* frem all af which ar* dartvod from Industry, Barry and Uwintohn s data may b* thaw an inertatt ta risk with incraasing undtrastimaias. Th* maximum duration dot* of dust, and w* find ao ovtdoaeo of follow-up ia that study was 23 ysart. ,, within tha run** of duet levels studied with an average follow-up of IS yam. for a threshold of due below which Observations from Finkaiatam* data ihtrt is ao evidence of riek" (Ex. S4-23S (his Tabia 1| dmonttrat* that only * p.**]. Ia general all tha risk (a/M eaaasl of tout fncidanc* was aaaresreanta aao cumulative txpoaori as axpanancad ia tha first 24 yam sines the measure of exposure for all caaur first asposura. That it. in of th* risk itdxuttt (eumaiativ* exposure asbtstosis incidence was not tspr*asd equaling mtonaity timos duration of performed for asbestos. This was updated fa 1003 by Achaean end Gardner (Ex. M-243). The report dascribes risks for lung eanetr. aasothaUama. other asbestos related eaecsre and ubaeteete end it contains a rather thorough description of the health haiarda ssaeciaisd with asbestos exposart. Tha British report's dak retinatea far tong aucar do not diffar in a motor way frens OSHA'* *itim*t**. For rcaaspi*. with regard to xpe*ure to anti) at lust 2S ysart from first exposure). chryootilt. tha Achaton and Gardner exposure. Thus, it ia likaly that th* low Given th* unesrtiindst inherent la lneid*ae* rat*s in ih* Barry tad ssaatitotiv* risk tit***sunt, st well ss Lawtnaoha study land therefore. th* low tha iMvttobl* varutfaa* in findioft update tut** that ~W* concluded that, for exaavpl*. an axe*** mortality from asbtto*-related die**** ef 2 percent astimat* prcdictad by OSHA) trt raflcetiv* of th* short follow-up pitted for this group of workers. asm* tha many tpidtmioioiic studitt. OSHA batisws that th* dlifartnt qsinUtstivs ntk ati..-attt ifrt* might be ttieciattd with any point tn a rang* of (root a flbr/nril to 04 fiberx/ml and that bearing tn the mind tha very OSHA b*iiv*t that th* bst ralativsly watt. Th* variations that do considerable uncertainties * figure stlmatM of <h* meidene* of itbattests exist ut bo axptainad by tha tta dies* derived from th* Finkaitwin assumption* mad* or Sy simpl* towards tha lower end of (he stray (0.4 f/ml| aiight represent an eppropnai* data. They Indicate that among workars npotad for a lifatimt txpooun ta i f/ce of asbestos. approximately 1% will develop tsbastosit. Paduan* tide lovoi D*thodolo(iui differences. Soma vartotiortt nay b* dua to difTertau* ia tha work environment uaad tn th* assessment!. cocgpromi**." (Ex. 04-242. p. 14). As a eamparuaii from TW* ll. OSHA s b*t eatimau of risk is that an axposuta to Ol fibare/cc (ml] would nsult in a 13 to OJ f/ee would rtdueo ineidonee to For example. Cnunp's rearetmant. percent inert*** m deaths from lung 1-J4*. It should be noted that tint* risk stiitai** mprosant meidswa of disabiin* stbeetoais. Kim tigno of advotso pulmonary fleets ara rtported to occur at lower level*. given at taatimaay to tko Ontano Koyl Commuaioa on Aabattu tn August TNt. oontatn* quantitative sstimatu of risk far aavarei atudi**. ineiudie* tmakm|^pcific risk attimstas. Crump cancer (or 1143 excess deaths per 180.000). VL'Tsstoriul sad Ceamsnto Feasibility Bated on an (valuation of evidence G Othtt QveniMivt Ritk Aummtntt dou not |iv* * barn tstimat* of risk or n ovartU risk ntlmat*. Hit tstimties of contained in th* record. OSHA finds that the provisions required by the ETS Sine* tart, mmol tatimtisit and scientific eomouttoot hav* tstireawd ntk astoetattd wtih atbaatot axpoaura. (Ea*. *!. SW. Sf-ad-l Tha risk aiKtinmu art in approxmult enreemcnl. They all use tpid*mioiot>cul stadia conducted m iha octspstionol risk are b***d soon an assumption that wsrkar exposure that would ruult from a standard tdt *t a 2 fib*r/ce limit is actually much tower than 2 fibers/cc. That ia. hit risk estimate sliders 2.0 fibsn/ce standard assume* that average worker exposure would be only t.O are tochniully and reoxemieatly feasible. OSi IA hat exammsd the venous industries and work operations impacted by th* standard *nd their ebilily la comply with the provisions sf the ETS. Because th* ITS requires prompt reduction of risk. OSI IA DUP 0907262 DU 028363 Federal Re-isler / Vu|. 4$, No. 21S / Friday, Novi-mber 4 m3 ' Sales Rrsutstiops SV.Jj incited the industry's Ability to implement the required contruls irnmedintely. The ETS illewt considerable flexibility m tehimtng the FEZ. A* i result. three opttots ere eveilebie to lower th< esbestof fiber eoncumreftons lo whieh worker* hr* exposed: (1) Engineering contrail such ee sutomstie bag opening devices. epeeielixed veeuum equipment end increased ventilation: (21 work practice*, such ee wet treatment of the asbeite* material end Increased elesa-up of (he work place, and (3) use of approved respirators. Due to the emergency neiura of this action which requires immediate response to reduce worker exposure. OSHA assumes that respirator* will bo the initial method used to eempty with the ETX A full discussion of the technological and economic feasibility of the alternative methods for each industry and for the various PELs under consideration for revising the permanent standard will eeeompany the proposal which will bo published leparataly. 0SK4 believes that, consistent wtth the estimates of current exposure levels, engineering contrail art currently in place end work practices, in operation which, if applied conaciesdoosty. would immediately result in concentrations at least a* low as OJ in meay industries (Ex. *4~1 Cx. *4-2*3: Ex. S4-C end Ex * M-2M). For purposes of assessing the technological and economic feasibility, however. OSHA assumed a worst-ease scenario in which each industry segment would have to implement a respirator program in order to achieve immediate reduction in worker expostiro levels below the estimated current concentration*. Furthermore, for purposes of worst-case analysis. OSHA assumed that none of these industries hue any respirator program except (or the shipbuilding end construction segments. OSHA makes this assumption because OSHA estimates that meet workers in industries other than shipbuilding end construoaen art exposed to eight-hour time-weighted averages less than 2 ffee. and the OSIfA standard Issued tn iVt only requires a respirator program when enginesnr-g controls tnd work practices cannot bring txpesuns to 2 f/ce. To the extant that asm* Arms do have an existing . respirator program, the costa art . overestimated. A. Ttdiaical FtotihilHy The following table presents the assumptions OSHA made regarding tha respirator program slsmtnti required by each industry to obtain a PEL of 04 f/cc. The typos of nsptraton needed for each industry sector wot* determmsd using the ttspirator selection table in tha STS with rsftranct to the istimatsd currant exposure conditions. OSHA assumed that the ice t costly approved respirator would be selected. For example, where industries have exposures less than tan daws the PR- OSHA anticipated that disposable respirators would be pinchesid. because of their lower short term cost*. When exposures sxeesded ten times the PB. OSHA assumed that some plants would either use air lute respirator*, er full fseepisee respirators, depending upon the operation. To the extent that Arms choes* higher-coat respirator to increase the protection fsdor or durability, respirator easts may be understated, funhirmarx. OSHA hxt not included in the cost analysis a consideration far lost worker productivity due to weenne rcsoirators. Costs may be understated by * ruinvar amount productivity is reduced. Other anticipated respirator program elements required to determine costs for tits ETS era listed below. These elements era derived from the existing provisions found in the Asbestos Standard. 28 CXR tn&IOtn end the itanderdt for respirators. 21CFR iro.i34. All of the required respirators and filter* era reidily available end eon be purchased through local distributors. Since the program relies mostly on disposable rstptrator*. OSHA coostders that then will be no supply constraint*. As the worst-case (or high) estimate. OSHA assume* that approximately 10.000 worker* will wear respirators because of the ETS whe did not previously wear respirator*. OSHA has concluded Ural die use of respirators will be sflsctlvt in providing improved worker prolection during ths period of the ETS. In addition to encouraging generally more widespread use of respiratory protective measure*, the ET! will stimulate t heightened understanding of the health haserd* bom asbestos exposure and will result la men effective use programs end strategies. Issues involving the appropriateness ef respiraiar use as a long-term solution to controlling asbestos exposures art raised in the section b| rulemaking processing (set lx. SM410-34. *4-347. *4.MS). SUMCMUMse 0 * DUP 0907253 | ;* '/ /. O v W I -- i. DU 028364 51334 Fedcnl Rryilcr / Vol 4. No j',j / Krid.iy. November 4. 1003 / Rulr and Ri-s'imi.nr* T>8lf 16 Anticipated Respirator Program Elements Required to Meet PEL Industry Segment ; Primary Manufacturing A/C Pipe 6 ineet Friction Material* As&estos Paper iUtltt Floor Tile Paints, Coatings and Sealants Textiles uet Process Ory Process Seconoary fabricators Cement Sheets, Faper Products, Packing ana Gaskets Anticipated Type of Respirators Used to het tne PEL "I aispasaaie/wortuay/worxer 2 airline/planc (for tifgn concentration situations;* Otner Program Elements Full aomin. costs^* Fit Test Training 1 disposal}le/work*r/flay SOX admin, costs for portions exposed at 0.75 Fit Test Training (Notning for /EL of 0.5) i oisscsable/worker/day for 7*r of workers 7SX admin, costs Fit Test Training 1 disposiola/worker/day 1 oisposable/worker/day 1 disposablc/workcr/day 2 air-line/plant for nigh concentration situations Fuil admin, costs Fit Test Training Full aoann. costs Fit Test Training IX aoann. costs Fit Test Training Textiles 1 disposaDle/worKtr/dey # Automotive Aftermarket 1 disposable/wortter/day ncouiiding ana Ketacmg I air*line/plent IX admin, costs Fit Test Training IX admin, costs Fit Test Training i 0901264 J GO'7-3 DU 028365 Fadrl ScyiMer / Vnl, \a / Friday. S'ospmbrr . i?ra / Kuli- .md RfSnljcor.i Respirator Program Requirements (Cont.) 5113S Industry S Anticipated T/pe of Respirators Uttd ta Meet tne PCI. Other Program Elaments IriU Upttr Oasoline Stations ShipbuiIdlnq/Repair Snipounoing Ship Repair Nothing Nothing nothing 1 dfsposaole/worker/day for 20k of totai workforce 20% of aoain. eosts fit Tost Training Construction Inst*! lat'ion VC Pipt VC Sheet I dispesaole/norker/day 10* admin. casts fit Tost Training Roofing FaIts Nothing Oeool 1 iion/Aenovatlon.,. I HCPA full fact for 2$S of tna workforce 2SS admin. costs fit Tast Training Repair fc Maintenance Nothing --aaooaaaaaoaoaaaaaaooaaaaaaaaaaaaaaaaaaaaaa--aaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaat OSHA assumes that cartain jobs such as clashing of vaevua equipment will produce exposure levels graatar than 10 tines the PU Consequently. OSHA assuoes 2 aw line respirators iil ta required par plant axcapt for seal 1 operations wnicn will require only one air-lint respirator par plant. "Administrative costs raprastnt tna salary of one full tlaa professional at 30,000 par annua and one full tiaa Clark at $15,000 par annua. OSHA nas aojwsteo administrative costs to represent expected reasonable tlaa spent administering a respirator program in each industry, in tna secondary fabrication and automotive afuraartet sectors, for example, OShA anticipates that supervisors will spend 15 ainutas a day distributing and non Us. ing the use of dispesaoie respirators. These sectors have far less of a management burden than 1 trg* firms, -and thus, administrative costs art calculated at l pereant of the fuii administrative amount. OSHA balievts that administrative casts have been overstated in most segments in order to prasant a worst ease scenerio. c0SHA mum that every Mployea out be fit tasted for,respirator use at a cost of $21 par employee. "OSHA has allowed 3 hours for respirator and asbastos training. OSHA considers that this is very liberal, especially in industry segments characterized by small punts and by the use of disposable respirators. Costs for this eleaent are therefore overstate^ ta present the worst-ease scenario. auaa mi M4 DUP 0907265 Ji <*\ 'J Lh' " ' / A 4.. DU 028366 rocrai ncunvct i m. . ,<u. ^ f frtcJy. I'.ovcmugi g. iou , *U1*, OS! IA alia sstmiiwd th* fsusibiltiy of analytical methods for measuring ssberius air concentration* *t th# 0.) f/ cs limn established by the ETS. 0S1 (As existing standard require* that all msssuramentt of airborne conesntrs lions of iibottp fiban bo mod* by tho momiiron* l^ter method it 400-4S0 x (magnification! (4 millimeter oultetivo) with phoo* eontrtot Uiummstisn (2* Cf* maiOOI(sl). After reviewing th* roiovmt evidence mod* available taco tho 1*75 proposal OSHA find* that pha* eomroot ftieraoeapy i* a feasible and ofToctivo method for measuring airborne asbestos fibers to determine compliance with the permtosible exposure level* oat by the Emergency Teaportry Standard. Th* moot important iitua railed by commona to th* IKS notie* la whether phao* eoatraot euerooeapy oaatyoi* is eapahl* of raiiably measuring airborne eoneentrationo of OJ flbors/ee end Its*. OSHA acknowledge* that aibooto* airborne measurement procedure* mini phao* contrast mterooeapy. a* with any indootnol hy|i*n* onaiytieal procedure, inherently contains several error caress. These errors have been statistically eveiaated by LakM *t *L ** (Ex. **-*21 and. in 1*71. by the Air Monitorial Ceaaitta* of tho Aibestos lafonutioa Assodition/Nonh America, rtfarrod to beram oo A1A (Ex. II 801) hath uoin* rauxd-robin saoioio exchange data. Chatfiold also axanumd thla queotion (Ex. 14-31*!. hi tho Uldcl at sL and the A1A evaluations, the error, mtssurtd aa a eootrieiont of vorlatiea (CV), was fauna te be raiated to the number of particles counted Iron tho Altar. Par 100 fibara counted Laidal. tt al. found o CV of 0.13: where** the A1A report found o CV ot 0.3S' or ofrort aosoeiotod with intorloboratory* intnfiiiar variability. Based upon those studies, taken at thtir fac* value, tt appear* that the phase contrast microscop* analysis ia eapabls reason* bly reliaMe measurements at OJ fibors/ee. A* Meted in the AiA report (Ex. I* Ml p. AM The calculated results indicate that tin tv AiA isaanilM naans sarawawCY tar xr^S >sruMy ia Iks Marts svstasnsa wro Stas TaaOva iiw.htw Si saoaW **4xa*w w*TVi~toUi niublm tta'wk i(u.scMimW~sMsonattisAaaeawBiasowse>a--uarbmr>Ma >iiwiinnuaas>rs mt.Mrp at rwaimm la A mmm to*--tally UxianrU Maatwa rnsno m* am* rawn* at awiianiaia >1 n nuw.MMaiii. <mI a-- >m m apuaaan to iMaia ildti issnw to Mttouaa Otto latoaaa^tMaa itamanp.SaMaat h. towift-f *SS confidence limit* on * measured * B. Economic Fvotibihiy hour TWA can b< rdsuvely constant with anils, but usable. rsn|u dawn to concentration* spprosenmg OJ fibrs/cc (Isss than(ill" Th* Industry easts lxted on tbs program tletnonts dssenbsd In T.ibln t* *f* presented m Tobl* t7. For th* ETS. the tests ef asbestos training art Th* AIA report shows s hi|hr error Included with respirator training Cast*r than dots tbs Uidsl tt si. report. On* for warning sign* ora not included, possibl* rosssn for this different may tine*, for tho purpose* of th* HS. these b* that th* AIA rtport sssasstd th* sign* could be band-eud* at very low variability in msssurs.-sants as they ora casts. OSHA did oat analyse costs betng mad# today by tho many laboratories wha ora making th* ewasurttMms. For example, only *7 of th* 40 Uboratcrleo pameipatsd in th* PAT program end no Hunting |uidalinas were given. whereat. th* Loidtl at sL aiaoeuttd with the alttnutr benefiti scenario (So* Tobl* 4) tine* that scenario was eonotructod to shew a lower rang* of benefits but does cot represent aa ettimat* of currant industry practice. report included only s small numbar af Tha costs sn overstated to th* txtsnt laborstons* operated by Johns that soma firms already have s current Manovilla Company, that probably asad very similar procedural and conducttd similar training. In la to 1M3. Chatfleld prepared a report sntitled "Measurement af Asbestos Fibro Concentrations m Workplace Atnaspherss" for the Royal Commission on Matters of Health and Safety Arising horn the Ut* af Asbaste* bt Ontario (Ex. *4-n*l. Chatfleld analysed Ultra-.-.- .itsr-labceiwry variability end arrived *t conclusions respirator program end to th* oxttnt ihat carsfid application of existing engineering controls end work prseties* would raduoa santtniratiara* to th* PEL in asm firms and thsraby mak* respirator us* unnecessary. Furthermore. tbs cast* assttnw that dust masks and filters will ktvt to b replaced ovory S-hour day. Some of this coat (i.t. th* diapesabl* raspiraun. fillara and administrative svorhaad) ean ba ia fact spraad over tho ported during which the ETS Is in effect. somewhat lanilar to tho** of AIA end UtdeL Outfield else rtcommended methods by which the accuracy and precision of phase contrast microscapltf saalyUexl techniques could bo Final!y. th* cast* assigned fa tho Shipbtiildiaj/IUpeir and Conttnrction* OMMhdoa/Mnovatfan Mgaaeu ropretant cort which rafict tnussrad comp!lane* with entrant ebiigetteat la g. improved. Significantly, ha noted la increased rwpirator ssa t* meet the raw af Ih* number and frequency of estreat standard u raeuit ef th* ETS measumatnti rtqutrad. tbsra is training requirements) and are set eumsiUy no fsQy davoloped altsmstiv* directly attributable w th* m. method |ts phase contrast mierescopy] which eauld b* immadiatsly tmpltmcnttd.* OSHA notat that tha authoritis* died NafaM^SHA sadMHia* Pot th* ETS will i*mt suy --lys wt* prsrwMly wars ' aat m sempliaMs ta sxpsnd A* MGsusry msasrsss in srdar t* sunn tat* s*m*lijr.<t above believe that it may be possible to with tk* ETS. nduc* phase eoatrar microscopy error* if Improved sad standardised procadaras *ra toUewed. perhap* by adding rtquintie*tv to the staaderd. It do** not appear, however, that frapraveffitma af this nature ean be qmchly made in tha tsamediafa format of tins CIS. Tharafen. boaad oo tha evident* before u at die time of tasuaac* ef this emergency standard. OSHA belicvts that it is generally not Th* fatal east It eetimeted tt SMW.403 for*months. This translates faw an avenge east per employee of KQ*. Avenge month cotta per worker presented t an industry basis ia Tab!* 17 range Erase gut ia tho autemotive eftermarket segment te 973 bt th* constructlee segment. The** eotti ere net e Itrye portion of industry shipment* t presented fa Table t*. Mortover. firm* fa thee* industries wtU be able te poatibl* to measure esbeato* pete tha casts forward bacaua* asbestos cencsatrationt below u f/cs reliably and reprodueady using phtne contrast microscopy undir etrrtat Uiberatory practices. 0S11A finds that the phase aubstttuta* in moat Industnta art nut hnmedistsly availabla. For all these resaons. OSHA finds that th* ETS is economically feasible. contrast miertneepy method ean b fcusiWr ussil tu racusuf* ssbesto* air eonenntniiiom ilawa ia OJ 1/cc. DUP 0907266 J 007 ^5 DU 028367 rtaern Kegt.ier / voi. 4a. rsa. t rnoyy. .nMem.rei * Tool* 17 lltlUUt Cut! Of (osgiriur fro^f* for ITS ttn f(L of O.S Industry Sotnont Armory Nonufosturiny Mconoory foorteturt Autontttv* Aftoraortot Totoi Costs (t) 1 . yiir 0 nontnt 0.400.0*4 o .us.so; I3.S47.J24 ,ois.ssj 1,0.W7 1.147.1*0 *-oo- 4or40* Coit/orolo.o* 4*1 44* at Sotpout totnvroooir CiMtruction S2I.2M u. 121. no U4.SU l.SM,flA su 071 Tout . W.SU.4U 34.S4S.40t 70* r**i* it ns Cmiiioci Coots Contort* . U Solot Or iMiStr; SOfMnt tnoustry Sofnint Cats/Solot Art*ory A**yf*eturin| A/C Moo 1 Snoot ffttti* notoriois ASMStOO A40r Mints, Coottnft ono Sotionts Sottots. Soots on* foctinst root!lot . Iwouiry fanrteoiors CoMnt Snoots floor Aroouctt Alutiaos OM Sottots Totttlot AuttMWO Aftormortot Sotut loins on* Aofociqg SMOOui l0l*S/A*OOir Construction .003 *00t .OM .003 .SOS .001 .014 Oil .072 .on 010 .014 .0004 .0001 .0004 Mto: Solos roluot oro for 1177 ono l7|. osluos for Aritory noaufocturtnf ono SoctMory fooritotort uoro toooo fr* **-001; .oluot for SM Automsut Aftornortot <*' tojoo fro* CrlalMloiuiitrrtut.r;su:iil'.o-nO7u1t lro.t.o"tl.i"T..1^.0.i.1r.3m.: TionMM.'Vo..li.ut.t.o.'/.t.U..f.o..gr...w.S..*i.i.i?.O.*.*.*y..i*.lO.'.S.i*..Sg../.t.e.*.O.m.O. .tr oTTn""o0 Olo for COMtrust ton oolustoo #/ tuttirociins ui* *iu* for MtfOuoy S Stroott ono lostooottoi ono oaotif tno oi* for Oxtlitiao/irtaiM. DUP 0907267 I pi r r * c DU 028368 S133g federal Rcyttifcr / Vol. 4, Nn. r.S I rd*v. November 4. 1W3 / Rule* ami Reduction! V1L Environmental Impact Requirement* of Executive Otder 12291. and the Retuiaiory flexibility Act Tit# Nenonal Environmental Policy Aet INCPA I af 190 (USD 4321 tt icq.). implemented by ih# fuJcline* (40 CfR Part tJOO) of tit# Coutreti o Environmental Quality (C*QJ. require* that ftdenl ipencie* aiaei ihair repulatory acttorn to dettrmiit# tl then ta a potential for a ii(mfiuni impact on th quality af lb* hitmen environment and. if aecoaury. la prepare an environmental impact itatamant la accordance with th#ta requirement! and 001SXPA rttulauotta fa CPC Pan it (Subpart 8. 1U0 (a) (4)|) OSKA had datamined that bacaua* of tht emcryency naturt of thii itandard. no nvironnt#ntal Impact atateaetu will b parparad far tha ETS. Th# court# k*v* held that NXPA daaa not faquir# advance pnpantion of an environmental impact ctatamant far an OSHA ETS (Dry Color Manufacturing Auocauce v. US. Deportment of Labor add POd 9*. tor (3rd Dr. 19T3IL OSHA ` win a#eaa. kowtver. tha environmental affect# af tha propoid permanent refutation tl aabeatoe. Tht rtauita af ... thia atudy will bt available for review and comment prior to the keannt* #a tha prnpoaad permanent itandard and wtU be a* appropriate taana for dlaceaeton at tha public haartnf. la the hitanas. OSHA welcome* any eenunenu an any tnvtronmanui affect# that eufht tocuru a matt of pramui|ation af a rule an aabetet. Eunuant to the authority of Section d(Hl) af Executiv# Order 122M OSHA hoc not prepared a RetuUtary Impact Analyei* at tht* ETS. Preparation af euch an analytic we* not practieabl# for OSHA io perform m tim# to icaue thia ETS to rnepond ta the tree* danpera faced by aabattea tipoead worker*. OSHA. however, n conpltia| a Preliminary Refulutory Impact Analytla of the propoml la revue the permanent itandard which will be made public at tha tim* the propeial ia puUivhod. The Regulatory flexibility Act require* an afuAcy <o pttpart a Rrj-jluiary flexibility Apaiyit* only for tha*# rule* for which a notice af propoeed ruleawiing ia pubiwhed. OSUA i laauanct of an ETS that#fon it not covered by tha Rffeialory flexibility Act barauao the OSHA Act provide# that CTS't be booed without roeard to notice, public chmbcoi and other requirement# in iko Admimatmtivo Procedure Aet Tha * prupoxul to reviu* tho pHtnuneni aWlu iiandani. however ia luhject to the rcquiro-mimt* of the Ri-qulatory flexibility Act and OSI (A will evaluate the propoiat to licertmo whether aiwiint under the Rcjulutury flexibility Act u .uqutred. Vffl. Summary and Explanation of iht ETS The requirement! of thin m#rf#ney temporary standard r mi out in nw Birifraph. f 1910.100111c). Thy re limited to iddmontl provniont to (h txiitinf (ibctia# itandard which OSHA eanatdara maatiai and faefibla to protect tmployifi from the pave daoftr reiullins from itbaatoa axpoiura until OS! !A can promulfatc mere eoaprehanatva revtuona in accordance with action b| sf tha Aet. Tha major chant** m tha itandard mida by the ETS arr (11 The new parmilaiU* txpoture lavak (2) method* of compliance permitted to achieve tha new (aval: and (3)requirement for the eetabltthmeat sf tremini promem# within 30 d#y*. The foiiowmt action diicu**** the nujer previtfon# of th# ETS. th# neceiiity for iochtdins lkata proviaiana in th* ETS. ind torn* additional previaiont t# nriyer aeriain requirement* it th# reduead panuuibl# level of (U f/ec. l. Paragraph (kXt) Scope. Aipanaf the ETS. OSHA it addin# parepaph on ih# ecop* of th# itaaderd. The paragraph ia iotandad to makt dr that tha m#r|*ocy itandard appii** to all watkpiaea whara employee* auy b* axpoaad ia ubaits* in all induatha covered by the current aabaatn* itandard te. (antral Indnatry. ooZn.aPtneircetpiornepahn(dkmmairiPtiemrme.itsihJo /eve/ ofexposure. Aa pan ef tha ET5. OSHA la addins perxyreph (kXll whieh *et* a saw PEL affective Immat iiaiy, a! Odd ce on an I hour time wet(hted iveratt b*#t. Thia reduead level may b* achieved by any foaii^lt combination of ontmoatuif control*. Work pracheae and reaptraiory protection in order ta allow employe** to inatiteto effective mea*are* ta rcduc* employe* expoeure* jnc^jltljy, OSHA eh*M 02 f/cc at iha aarmiaalbia etpoaur* ieval primarily oocaita it believe* that reducmi tmploye* axpoaure# to dJ f/cc in all indiMtha* will (really reduoa tha nak of davelopinp ubaatoa induced cancer*, pnauniy liay cancor. maathaiioma and laatreintasiinal cancer. A* at out in the dlaeuaion oa *|r*v denier" and -benefit*", th* number of Uvea OSHA baUava* maybe aved throuph * immediate reduction af axpoaure t* Oi f/ec ia auhitanfiuL OSHA alao believe* that ih# 0.1 f/ee level 1* appropriate for oversi ether reeuoni Kim, baoiua an emergency itandard-meat bt faaiihl*. and employer* mutt be able (o comply wuh the nundurd >n * ei'ort pnnno sf lime. OSHA h Ml a level which i* Ukul> to bt achieved immediately, unnj equipment and eamrel ttchsiqut* that , ere currently eveilabl*. Second. OSHA believe*, bated on tht data (imereled by OSHA* contractor. Retearcb Triangle Inaututt. that lome workplace*. oopieeeally In th* manu/aeturint actor, may be cloi* io ichtrvtnp * 01 f/ee level threu|h the more riyorou* eu #f m(m*trin| cootrel*. work praetloa* and houiakaapini mothod* which are now in pieea. OSHA ancourain amployer* io continue Ihetr afToru to implamtnt the*# method* in order to ataure that, for the fonp torn, th* moat comprihanitve and afTectiv* proyram af ptottchoa from ttbatto* aspoaur* will be provided. Third. OSHA believe* that reliability of th* eumntiy required aibttto* muaaremani mathoda to manure iioexio* Hpoiures lea thin 91 f/ee ihoald b* *P*n for diaeutmon dump a ruiamakiof hearini. rather than impo*d throuph an ETS. OSHA ha# therefore not adopted the 01 f/cc level petitioned by the union# but isatoad i* csstKUnnp addins previiioo* to th# atbettn* itandard that may improve tha reliability of both umpUnp and asalyaia in tha Mb) nilatukinp for th* permanent itandard and thua allow lower level* to be reliably manured. 3. Poregniph (LJfSI Methods of cootpfionm Tha ETS adda a new panpaph (kX3h which permit# empleyere ta redue* th* parmiutbla expMura limit from th* current 2 f/ee limit ta the 01 f/ee limit by any ftuiibi* cembutation af npiner control*. work practieif and retptretory prataetten. Th* current requiramtni in paraprapha (cHD and (cH2) to fimt uUlia t&interop control* and work preeticaa ta reduce axpoaure level* te 21 f/e* remain* anaflactad by thia ETS. Flexibility in chsocap ampliane* tretepiea for Ih* period of as ETS ha* been incorporated in meat other prtviouily lisuad amartancy ttandard*. The policy refiacu OSHA'* dammunatioa to craft aoarpeney itandard* that are truly retponaive to emery*n>' condition* and which aiToril fmmodiataiy aveilabl* protaetion io aiTactad worker*. 4. Paragraph (kj<4/ Employee information end tnathtttf. The ETS iddt parepreph to th* aabeatoe itandard requtrlnp th* erepiayer to provide * traininc profrem within X day* of publication af.th* arrerpancy luntUrd for ali employ*** whaa* txpoiurev nrr reuaunuMy axpectad to exceed the PEL of 01 f/cc without retard ta tha ute of DUP 0907268 J Q07 47 DU 028369 Federal Register / Vul. 40. No. 213 / Friday. November 4. into / Rules ami Reiulations 51 US rMpiraton. and (o sisure that all such employe** psrUcipaie m the pruaram and are In/armad sf specified euicanriim of information. OSHA cuaudcr* this provision to bo "neaeeaury" wiihm th mssnmg af section e| of tho Act. to roouca th* |r*v* dyifcr faced by aabooto* exposed wtployeer. Thu obooneo of a trotmti program raqufcrcant la the Jsbette* ttuadard baa boon pointed oot os on* of tb# sorieua deficiencies of tb* eomat standard. OSHA botiovo* that ponidpodon to aa adogaoto Mining program ia oaMadai for th* protection of ompioyoo* beeaaia moat proiuctivo provisiona onliat th* amploye* oa on aetiv* participant. For example. many mployeos handlmg aabooto* dooond on rlTvetiva work practice*. Without trsining ta applying tboo* week practice*. ompioyoo protection would bo madogoot*. Wbor* tha omploya* pioys a mar* poasivo roi* ia bio protection attch t* where ongtooartng controls or* mllod on. training ia aioo ossontioL bocaoM tho employ** moat know th* source* of workplace aabooto* cantomiaadom and tb* booltb baurda of taboato* exposure, to ordor to aasaaa his owa txpoaor* siiaodon and to bofp rtoogniw **b*o engin**ring aantroia an oot oporating pooptnly. Carumly wbor* heustkaaptng ploy* an importaal ni* to eontni. tostroeflon about booMboopiag methods. fir example. (roguont vuouumfogi to essential. Perhaps most tmportanly. whan amployo* pratastiea depends upon rasptrstor os*. OSHA* experience show* that training employee* Ir. : i us fltdng and Umumeas of roapirotors ts critical to th* offtctivtnoM of roapintor protection. Accordingly this rogutramaot appiioa wbon oirbont* cuncoaintion* an reotoaably expected to osaood 94 f/ ee. tvtn if employ*** to* ntpMtors to rtdueo breathing tan* toocomndon* and thonby eoftpiy with tbo CTS. Aa sat forth to parognph (kX*) th* omployor meat inform th* ompioyoo of th* health offocto of aaboato* exposure th* ntaUoiiohip bottoooa aabooto* and smoking ia prodoctog long cancan tbo oporadona ospodiM ompioyoo* to oabooio* Mmn msaaooooary ptotoctiv* etopo to mtoUmln* oopoooni tho purpose props* oa*. fitting toouttedona and UmHattoMdfmentor*, and the ootMom ofhi too pemdaitno of tho Aabomao Stoodora at 1*10.1001. ( Aarggnp* (kM$i Rtaviratanpmtrrjion during tho S7S. The ICTS adds a now paragraph (kgll which includes o tabi* which duo respirator rioction t* th* 04 1/cc m. Untler the ETH. th* concentration ciit*u(T (nr ramies kind* of noptnion an multiples of the reduced PEL of 04 f/ec Authority and Signature raihcr ihjn multiples af the previous 2 1/ es permissible limit. Far example, spprovtd sit purifying tespoiitor* may be used only whore isbesto* eoneanirutinns in not tapeeted to taeeed I f/ec DO s iha PEL). Defer* th* T3. became ih* PEL was 2 f/ec such respirators could bt used where asbestos concantration* would oot have sxcesdtd 20 f/oc (10 a tb* PEL of 2 f/cck This document wt prrpured under the direction of Thun* C. Auchirr. Aooistani Secratsry of Labor for Occupational Safety and Ifealih. U5. Department af Labor. 200 Constitution Avenue. NW. Washington. OC miio. Pursue** ta Sections Sib). S(e). ttel ami Kg} af tha Act. 21 OX maion is nmandad by adding a new paragraph (U as tot forth beiow. Simiiariy. poworod air purifying respirator* soy b* uatd whara aaboato* lines. bk tick tj atd ). Pub. L Sl-UC oonconMtions do oat wooed 190 uow* tho PEL which it tb* now lovai of 04 ff ee is M f/ec Pnvtcuoly. employer* MtM.tm.imtm taaftauxc.ua airs Sue tor. hx L si-*4. u u<i. aa no U4C JSSiaCniNfl 1*11. Stersisryoi Lslasr't Otdsr Nc *-B (4* PX1STXII could have used such ntpMters at eoneontralien* up to 200 f/ec lignad si Waskuigisc OC. tkis an* djy ui Wsvembsf tma. It is llkoly that th* mala impact of tho Tham*C.Aaaht*r. rodoead FIX oa respirator choice will bo la oporadona and indaauto* whan AmmMtUmmnofUbaf. exposure level* ora between l f/ee aad F4XT ItlOwfAMCNOIDI 20 f/ec Formaoty, snployoos exposed in this rang* could us* half-mask air Sacttoa 1*10.1001 of Fart 1910 af Title purifying (aspirators: now they must b* & of the Cadttf Federal Regulation* is protecttd by s powered air purifying kertby tmanded by adding t now nspintor or a full faeoptcc* respirator, paragraph (k) reading aa follow*: or they may use s tapplied air napirator. ,, I ilictaai gwaatac 0. Porogroph (kHQ. Wonting lipra during tho CTS. Th# CTS raeuira* that logibla signs waning of the nooith heard* *f aabooto* bo displayod at loadoH wbon tirbom* oooeontntiena of oobootos Char* tteaod th* raduead exposure limit of 04 f/cc No apodfle legend i* regalnd alga* for newly postod during the CTS. OSHA wishes t* stake u practicable aa poasibl* Ih* rapid posting of signs. tsoootaUy in worfcplaao* .ion dan ho* been praviaas aon-complfane* end is anas whan aaboato* esncMMUons won formerly beiow tb* LOf/eeFEL % XLFobSeFsttic^oiioai (k) flmgauy iwtparwrtuadard offtetriu Ntntiiar r. ittX--(IJSeepa. This saaigwcy lemparary standard is lasaad aarasam ts ssedan c] af th* Act and applies ta aQ workplaces when employ*** maybe exposed te asbestos to *D ladusiris* MVfrad by tha Act. todadtog. ganeral Industry, canstrucuoi aad mandma.Extapi to th* extant modified by thie emergency temporary standard alt wwitiens *( | lOlO.JOOi raeneia in efTsct. (2) Hmiutkk k'ttlt ofexpoture. Th* g-hour ame-wetghied average airborne eeaeentrsuoa of tsbestoi fiber* to which any employ** may bt Intonotad peroon* an tnvitod to submit v-nttotudtta. views and argomaats with nopoet to the revisions ts th* aabetto* standard mod* by tbo CTS. Then comment* must bo postmarked on or bofsn lanuoij X IN* exposed thall eat exceed one-hulf (041 fflber. longer than I suenmater*. per cable ccmitMtaraf sir. ss dstsnmned by th* SMtbad prasenbad in paragraph (a) af this taction. (3) Aferhoeb ofcomplionca with the and sent to tbo Docket Officer. Docket No. 11-413C Occupational Safety 4 Health Administration. US. Department of Labor. 209 Constitution Avenac NW* Room $>0212. Washington. O.C. 20210. oomrgoacy umpowy mndatd. Notwithstanding tny other raquiremen of this section, compliance with the reduced exposure limit of 04 f/ec ihni: b* tchitvtd by any feasibla Tbo data, views aad argomenu that an submutad wtU b* avaibtbto for public inspection and espying at the above address. AD timely written lubattstiOM will be made pari of Ih* reoerd af the prootedinf. Ust of gbkjects in 29 CFR Part 111* csmbtnaiiaa af engineering esniroit. work pracKs*. and patsaacl prou-ctiv aguipmeni and devices. (4) imptoyoo information and triintm-MH As soon at possible, but Ml later than thirty (201 ilayi fmm the dticUv* dale af this emergency temporary standard, the empluyi-r sh.i Oceufauerait safety nnd health. Insliluie a trairuns program fur all Asbestos. Health. Emergency temporary tmpiaycct ttpoted to sirborn# uatujsrdi Cancer. .eencuntratiuns of Mbctio* m txn.-x i DUP 0907269 DU 028370 SlKfr Ftdtrtl Rector / Vol. ta, No. Z1S / Friday. November . l* / Rule* and Relation* M f/es. without rtfird to tho m tf pirn ion tnd thull ttturt their portieipoiion m tho preprint durtnf tho effective ported of this omtryeacy temporary tuadird. (ii) Tho employer thoil pturo diet each tuch employe* it miormed of tho foUowtn|: (A) Tho botilh ofToctt auodoitd with otbottoo otMourr (B) Tho mlatfanthlp bctwtto otbottoo end ttnokini ia productti| lunp cancan (C) Tho nature of oporotiono which could molt la exposure to tibooiao tad ncccttuy protective ttepo to minuxiit txpoturo laciudinf. tt applicable. tn|inoorin| eantrelt. work pndicat. respirators. houtokoopmi tad protective deihlne (01 Tho pvpooa. proper uto. BUin* instruction! tad Uoutotiont of respiretore pomittod by tho tundaid: (Cl A review of tfl tho provUiene eonttintd ia IfiaiOOl. (l| Rttpiratary pnutet/aa Airiflf tho I7S Notwlthtioodint eny othor reouireatat of this toetlatv whort retpiraton trt ttod to tchsovo tho poimiotiWt exposure Unit of SB f/ee thoy thoil bo toioottd oeoordiu M ToWel. (S| Wanim$ t/fitt dureny tho tlS. la ,,ddifioa to the requirement! of pomtrtph (s)( 1) of this motion. lo|iWo ntni warmnt of tho heulih husirdt of tbetiot thull bo provided ond dlepioyod t itch location when airborne coacontrotiorvt of tibcttot fiber* may oaoood U f/cc TMU t (MtirtUr; Nuttioi for Atroorne Concentrations of Atoostu . Aireeme Center*triuon Of Altottot I TWA) hot to tutu of > f/ee uo a nn toe to oicett of to f/ec c too X fUj irtttar Ua to f/cc JlltjriHjj|iriUr' Ipoourmif/sioIoporrottteni>-t1oUurto otr foil ftcoptoeo otr port/jiot rtotrtUr, or t poooroo otr purtf/top rot* ptrotor A typo *C* cantitutus fioo or prnturo Oosooo, Wff1 too ttr rotpiritor. 1 Xotptriur* tpoctffot for mpi coocootrottoot oty to *tee ot itotr ctattttrttim it uaotut. (Sea. KW. del. del cad tty Sub. L. tt-ttt. UiQ. a* a O* Ht\ an. feature of at sue tin. as tm teas a uxc us Ukort Order n*. t-u (a n until Wi Stt 1ST. fob. L 11*04. AJ Slot tt (40 ntaMIIMMOumi s I t DUP 0907270 JG3I69 DU 028371 DAT!. 11/9/13 TO: OH COORDINATORS MOM: *MUIT1 ImlwMial AMWn NtrMtiimMt OtMiWMI MM Nunsun Mf.-Cst.4IMT nm Nr ^------ *R wm wt Nr At MR Nr Mr MM* HtftN p^mN TM MM Mm NNMW rum m Nr Vht Nm -f0; Asbestos STS. Pleas* not* training requirements for affected employees within 30 days. 'Jou noy S A Qutnorie& CfQlsup 579 DUP 0907271 POm OUbLOfthd A" ^ odd|4|J" ^ _i_Joblt lmi+ \?V \SZ <* ^ _ 0\> aouj doat^t +*>! 4na^ C<5<jauS luW, ^ W V\\eJ4 1 ^ ,x cep^ j 0 32 "8 DU 028372 Wday Maveobar.4, IMS . Part VII Department of Labor Doeupationat Safety and Health AdmWttnUon Occupational bpotart to Aabestoa; Emergency Temporary Standard * r* * ' DUP 0907272 Ju3??9 DU 028373 nm *><*** Knt** f VoL q. No. ai / Trufcy. November IPB3 / Rufat and RniliHam VII. Eaviraaamtal Impa* Rtquitantafa of Cxacudvo Ordac im and dm SotuiaAty naxihOJty Ad Aa propoaat to iKitlili whether catployara mutt ba able ta amply with tnatyiia under Aa Regulatory Flexibility At ttandard A a thon parted of lima. Ad fa laqwaaL OSHA hat aat a Irral which it likely to The National environmental Policy yW. bwraaerj'iod Expleatfiea af At Ad (NEPAI oOWfUAC 4321 d aa'.). m be achieved laiaadiately. aaiap fulpmcnt mid eonuoi fadtsiquae Aat mtplatAnttd by At (Adelim (40 CFRPtrt 1500) tf dm Couneti m Tbt requirtmcnta af Alt aneryency Environmental Quality (CSQJ. ngutna fadpsntv ttandard art aat tat A atw Att federal iinduKHM their rvfvleiory tenant ta driemne a Aon it pe*anatel far * etgmfleent Impact at the quality af At human irrmemnii and If ntmetary. tapctpanan envireamantai Impact atatamcnt ta tooordasce wiA Am raquiraraenttind 00L HOK regulation* (S CFR kart it tSabpart A nJO (t | (4||1 OSHA hat dtttnxlnefa Aat hamate af At emergency <un of Ala ttandard. at tavmamcatai impact lAtttMat will bt perpend far At ITS. flit ooarta hava held Aat NBA 4m notreguinedvaaatpraparetiaaafaa tanraatitatal impact tictantn far aa OCHA m lOry C*hu Mtmjftauring AatMotan *. US Dtpt/anml tfUidr at Tii Ml W (3rd Or. 1*T3|J. OSHA will natat. however. At envfaonnuil affects tf At pnpmj ptrmitcnt pvtrapb. 1iPlO.tPOlfk). Tbay art' salted ta additional pravtaioai ta Aa extettng atbaatoa ttandard wbieb OSHA ootuldan manual tad fauibia A pratad tttpioyam from At yrava daatar raauhlaq fraat atbaatoa npmai ants OSHA can pnatnulitta mart aoamAtet.aa rtvHtaaa A aaaardtaat wtA taction Kb| of Aa Art Tbo mafar chaafa A Aa ttandard mad# by Aa ITS arc (1) Tba taw parafaaAA txpotxrt lavat (3J maAada af aadpHmt parmittod a oddttt Ao aaw favab tad (1) a raqtnramaat far At aaubiiebmeal tf traMaq prapraai wtAA 30 dtyc Tbt fallowAt MAIM dfamsaa At atftr prtafatatt d At ETS. At ttettaity far AtAdAf Am prttrttMM A At m. tad atm additional ptartrtaAoa A tA> ttfAA ragdramaead AatadaoadpanafaaAA -faveiaftJffae. regulation af aebeatae. The ramita af t Ac--rtitit (IjftlStfa. Aa pad af Ais itudy will bt available far review At ITS. OSHA fa tddlaf a aaraprapb audoamaaMpaArmthehemAgpea at Aa tom *f At ttandard. Tba *t|ta)iM4 lautiwi attndard aat parampb fa Ataadad A aatfca dm AM will be an qpnpiia Am far At ameytacy ttandard appltaa A al dActtrtan at the public baaAm waibpiam whan pkMM Aty bt A Ac Ataria. OSHA wtltwii aay txptmui A ttbtttn A *1 AdatoAt ooamfltt aa aty qatlrtaaMitai tffecA amwd by At amat aAaataa that aught eecar aa t malt af fulfil-- afa Ida aa aabataa. tAadaid A pawaral Adatvy. art cwmatiy avaiUkia. fimad, OSHA btUcuo. baaed on Aa fata (antraAd by OSHA'a contractor. Kaaeareh Trtmpfr InaUtda. that aoaia workplaoas. aapadafly A At manufadviai aactor. say ba aim to aeAtvAs tUf/ae favai Ana|h Ao man r%amaa m afonsAtadns omwh. warit ynrtlraw and botwabatpAg mothoda which an tow A pitot. OSHA tamraiat amployara to oonttnaa Actr affadt A fapdamaai Acta matbodt A trdtr A aatart that for At faaq term. Aa mom oeatpraktneiva aod effaetiva program af pmccaan bnm aahaataa tnpoaan will ba pnvidaA Tbitd. OSHA btlirm that rtIUbflity ti Aa aanantly rapafaid aabactoa mtaturamait maAada mmtamnt tabaiAt tapnaarn law fata ni ffrr ahaaldbamnfar dfamntta AeAp a nbathAs miAc nthar than impaaad Anu|h hi ITS. OSHA hat Aartfara not adapted w U Ua fatal patmnad by At--Ant An fawtd It matfartn< aundard that soy i far Aapatsamt lawarkvtla A hentubtymaamd. ` wssstj: AK3I> whfah pwmtta Punuattt to At autbanty tf Saetita JUKI) af Eamtlvt Onfar 123P1 OSHA baa tot pnpmd a MguteAay Impact Analytic of Ait CIS- RrepamtAa af ctach aa analytic mat net pattticablt far OSHA to perform A Am la iaaut Ait IfanpA* (kXVf*nuw\k krai ftagtaearm At pad tf Aa STS. OSHA -fa addinp pant^apb AWO which aata a atw FO- aftaufra Amdistafy. afSJ f/ aa aa aa t hnr> am wafabtad atanpi haaA TbA ndmad touafAty bt AtparmAtibit --------------------Ae ewraw 2 f/oc am A At OS f/ae ten by any faatibia tmhAtlAn t/mtaaarAi tanooU. ward pnafacaa and raeptraiory pntttdtfl. Tbt marraf nptunmnt A CTS to ntpaad A At gnvt 3it|iw faced by aibtttaa raptcad wecfcan. OSHA. bewevtr. la aamilttAg a Prabaiinary Regeiatery bapacl Aaalytla ebfataad by tty fttmblt mtbAtdf tf tnsAaalns aeamia. nrark prac*m tad' laipaaxiry pwanfaia A arfaar A eilp-- paraprapha (cKU cad {cN3> A frat Ulttn aaplBiinTlai naatrafa and r irt pnettrx a nAm aapoaaie latrafa to mptoytaA AtAdt tfitdfaa 34 f/ac taanfan aaaSacaad by Ala CIS. of At proposal ta nvtap At parmaasi ttandard which wM bt mdt pobifa at tbettmc Aa propoaai A paWahad. - Tbt Regulatory noxAthty AA Atatom A nAmt tdpfayat < tBAatifaty.; -OSHAdmaSAffttnAt panAtBiUaanpmia Iteai prfi HttiMfay A diHtlM oompiianca t*tA(At far At parted aft* CIS hat Am tnaarpanAd Amoatathar pwrAuaiy tammd aAaiptnry attadarda. raquiraa an afaey It praparta bmtna balfamt dm aaAMdas 3ba pahqr nflim OSHA'a Regulatory FlaaAiiity AaalyiA only far mpttyaa tnpimurit m tS Urc A ti ' dWatmAartan A craft amanwry Am ntlaa for which a artAs tf Adtatfaf wtlyttdy rtdm At rfafc af rtaodairtt dAf an maty napanam to ptopoced talmmihfag ApahfbAtd dftfapins tabaaam ladaaf ctaona. twrpwcy mfiri--a tad wbkb Word OSHA'a ittgaact tf aa fcTS AcreArt It patmaity Map canacr. maaathalttan tad im iflinly aanSabla pnitcdan a aat covered by Aa Sapafatary mmAtaattaai ttnaar. At aat aat A At affactadwarfcan. Flexibility Act hionai At OSHA Act providaa AatCTTtba faatad titAaut Aacmfei ta ~|na dutar tad baarftfa*. Aa maabaraffaa OSHA. ftfoam.SaanfmantaoaHA mkwfnftamp.tTiobamCTS adda baba m may bt aa--d Anush am . a paraftpb A An aabaalaa ttandard ether leguinmeMa Alba Aaaaditta radadtan af tm*n* at PA npatrtbp tha anpfayar A pnvida a Adminfatntive faOBOfitn Ad. Tbt f/acfa aahtAMitJ. ArtnAt pnsna wtAA S3 dayt A propoaai to fttrtaa tbt pamaaaat OSHA alas bahtvst Aat At 04 f/at pablfatdan A tha anmpancy tnaadard itfeMioa ttandard. bowovtr it aabfad A faaai fa tppnprittt far aaaarat dhtr tbt rvquuvnentt of Aa Ragalatery naaaaia. Ftrat. boonwo aa atttrptncy Flexibility Act and OSHA teiU avalaata tiMdtrd mad ba taaaiWa. tad fart! anplayaaa whota txpamsaa art aaaaaaabiy axpaawd ta axatad dm FCL dU Uee. wMhMt rapnrd a Aa ua af DUP 0907273 J G 3 'L 'rO-0 DU 028374 rdrl Imfritt I VoL at. No. / Friday. November 4. tl a------m / Rulci and Regulation. tit ft retpintora. and to twin that ail inch taploym participate la the program muliiplm of tba nducad PC. f oj Authority aad SimMtaw rtdMt tkan aiuldplat af (ba prtvioua l It and art informed of apedfled caiaortaa ee pamlMibit Halt. Far axaapple, Tbir doemrwnt wat prtparxd widtr of infonnatioa. OSHA eoneldan thte apprond air purifying raapiraton atay die diiacuen afThorni CL Auditor. pravldoa la be 'Moataan" within Ilia ba uaad only where aibeetee Aaalatam gacratary af Ubor for neaamg of aaadaa Kc) af tba Ad. la aancantratieru art net expected la Oeeupatlonal Safaty and Hatith. Ui reduce tba gran danger (head by axeaad 1 f/ec (10 a At PEL). Before die Oapartmant af Ubor. WO Cenitltullon iabaatoa expoaad employee* 11m CTS. bacaaaa tha KL wai * f/ee. tueb Arrau*. NW, Watblngtan. DC J0110. abaanea of a training anipia raiptratota could ba uaad when Jinuaat ta faction. a<t. *). Kc) and requiramatt la the aabaaioa ataadaid aibeitoi coneartratJoc* would tot have m) af tba Aol S OH laituon la baa been peiattd aat aa aaa af the aariaua dafldanalaa af tba aatraM xeaadod JO f/ec (101 tba PEL of 2 f/ec). uxiUHy. powered air purifying paragraph (h) u tat fartb baiew. Waadard. OSHA baJiaaaa that rwpirafar* may ba aaed whan atbattoa (Sna pbt, mat. d aad ||. Fub U D4K parddpation in an adequate tniatag eoaetnindon* da aat axeaad 100 timet a Out urn. ima uaa laoat a uxc. ua. promts la aaaaniM far dM pwteerion of tha PEL. which at tht aaw level af 0J f/ wi laa. tar. pb. u B^a. as tut. at mo employaat becauee meet paatadire pravtneo* aaliat Ida ampteyaa aa aa ee la M f/ae. PreeiaMiy. tatplarwi eeald have aaad aaeb raeainton at UACillfemcygPantmt-.Saewwyaf Ubat`1 Order N* *-m (41F* Um adiva paibdpaiM. Far example. many ceaeantndeaa m te 100 f/ae. I it WaihuMiaw OX. ibla lad day d employee! haadiiag aebeetee daptd aa . blattaly &attheiwfciImpactefthe affective work practical. Wttboal mining d applying diaaa weak radaoad FBLeo napiiaiar toilet will ba la oparatlana and todaifftoi whan danbraargwwaary a/fader. gradient. employee prettcden amid ba inadapaaia. Whara tba employee play* a axpaaan fanle an between I f/ae end m f/oe. Formally, empieyaae txpaaad In FAJTr fOIP--(AMKM3CD] aMta paaalfa fata in bia protection aaeb aa when npmeutag aantrala an robed an. training a alia ananHal bacaaaa iba anpleyne nan Imew da aouroaa af workplace aabaatna cantominedaa. and thle mega aaaid aae haiMnaak air purifying napiraian: aaw they matt ba protected by a powered air pxhfyiag rtopirttar r a fag ftaapnoa naplntar. ar dwy may aaa a implied air Seettea W10.M0I af tamo of TlUt JO af dw Cada af Fadtnl bagulatlani U benby amended by adding a aaw paragraph (kj reading u faOowa: Iba health haaaida af abaataa aipoat napdratsc. |Nt to order to noooahioewB txpoonm Mtaraing afpat adaatiaa aad la help reeefRfsa arhan loginaartoa oonmah akciiM Me S7S Tba CT laqmraa Ifcal tarfble dpt waradiMef the health . property. CsmUnlyt kanrda af tMaaiea ba diaplayad ti playeaa Important naie tot iaaadMi* ahav abbanm ammi itnaaedenOIOtftha toatwedoa abaat haaeahaaptog . af aabaaiaa team tented tba radaoad Act ud appbaa m al wMbpiaen wban method*, far eaaapto.feaqaaii tapaft Badl of ftp f/aa. Wa apaidllr ttopteyen may be txpoeed to aabaetea vaaaumfe* la aaaaadal. Pttfcapa atoat tagand la ngrtwd alma far aatiidy to all todaatrlto aerated by tbe Act. bapaataaly. when tmpfayo* prataetim pasted darlag dm RSTOSHA wWma la toriaideg, ganarnl ladutry. eentireetjee daprnda upon raaplraler naa. OSKA'a experience riwtn that mtotag amptoytaa to the aaa. fhtina aad Uadtadaaa af itapbaiaaa la artleal la dia agadivaaaaa afraapintar ataurtton. Aaoardmalv tbu laadfant appliaa whtru amm manHIUl mcha aa prattabie aa poaalbla the tepid paadngafalgae. laaadaBy In wacfcplanaa wban tban aaa baan prartoaa aaa nampliinca and la anai wban anbaalra aaaMiainUaaa wan fmawili balaw *Ha U f/ae M3. aad toarldae. Exetpt ta the extent atandard al protoalaea af I maiOOi nmatotoaflbcL (J1 Ptmimibh kvttt tlvepoturt Tba bour titur-ww^"^ lifBbrpaenticungitioB^ io'io m nastun uim.m u> **2RTOt/ AMiiMdpidm ^TBBnB'SESiSwimiolovuttguvbu Ml ITSiwEtoM HWtouaian in lataructad p"MM wa brrliad M *mami imiiwi.e..d A'iO ih| ubaat wmian data, riewe aad nUr. loagrf (III 1 aucaametanja^r aaa tUnbycompty within III. aagaaMBia wdb raapu la tba mddmii Aa mTUAII pniiJJaph (kX41 da aatplayar anal tofarm tba amptoyee af to tha aabeeiM ataadard made by Om IV'TOMBM PndcnSBnaparatraPh (a) of ttoaaacdoa. u>a haalib affacU af aabaaiaa expeaora; peautaifced aa ar bafara laaaaiy . 10M (J) MMtodb afotmpiitMt widtAt iba wlailenalilp bafwaaa aabaaioa aad aad aam ta the Deehet Ofltar. Daabat amaryancy matparary tuntard. making la pradeatog tana aaaaaR the Na.H-raCOatapadaaalSafatyb Narwltbatandtag aay ether naaimmtatf aparatwi axpoatogaapnyaaato Hnhb Adaaniteattom US. Daparimeat af tola aaadan. eoaspiiaxea with tha aabaaiaa 8ban Mdaaaaaatfy paaMdlva afUbar.MDCanatWndaaArmtoa.NW. reduced emoaart toatt afftjf/ce ihail atapa ta i Bum *4111 Waridagten. D.C gOBO. ba acblavad by aay faaalbla proper aaa. Mng totaracdaaa aad amiiaUoaa aflaapfcawn. and Iba anatant* af aftdn aravtofana af dn Aabaam SMadcra at mPUBL The dm. vtewe and argnMAta that an aabrntoad arlM ba araitofata for publie leapactioa add eepytag at toe abera addnae. AS timely written eaatblnitlen af anglaaaflng control*, work praettoaa. aad panenal prottetivu actopaMM and davlaaa. (4) bmhtm inftmttitn and 1 Arm* (WW/tappdWBry admit iiaaa will ba made a pan af the pmraedmdMg (baC7S Tba CIS neaedefthepraaeedmg. adda a aaw paaavapfe (bid) whlab toriadoa a Mbit wfalch ttoo naplraiar Uai af gutoa^* to JO cm Part nto aiadloB la dM M ffaa PO. Uadar dn ETS. iba aameamdoa cai-aflf far OaaapadoMl aeftty aad baallh. toatituta.a ffttlill* **""*' *"*-* AthaatM. Health. Caatgeney temporary tmuerttt nwrt IQ aithagM vanaat klnda of napiraian an aiaadard. Cannar. aBtaartaatton* < aaaaaiaa ut axetn of J fv;7w 04 si DUP 0907274 DU 028375 Umporafy a______ (H)Tfcatnmwrahdlaaa-- ilm falwS ",>JayW k Uvm4 * W) ti ri^.kY ^--n mh, lt| || aprovidadi tuu 1 Imiriur; Prauctiaa ttr iiwm CMeMritiw * Ntwlrtlfm^i yy ftlfT n^taat ortki* mcuok tar f*wnten tn mo4 ! aebiMo Km y^M* **9Q*m toattafOJ f/oe tjjwr>a>taakcaadaocortfcio . dWdlUjZa*stosmtaatimltmatfaaaiinattHamfm. t ti *mit final H it ! |f 1 I/M (M1 HI) l too I Hs*lJ * *o *m *nu tta K f/ae O--Mtro* Quintal ar m ,r ***/<# fasoiraur rail fataaaa air mairatar, r I ir partf/taf r> imur A UM *C* Biuaatai flaa praaura aaattt, MOpltM air raaairttar. 1 OMftnun tMCtfiaO far eaaoMtrttiaaa atp Mwaatpattaaa ajr aa .taa at Am. U *). no aM . M. L MK M*MiaR.tiiatMiiataatcaK 00: a ur. fuki l naa. u <iai m UACcFari mi. iKwy .{ um* (Mw Na. mi (aa m anau DUP 0907275 DU 028376 [ Qsr~* PATt 11/9/83 TO: OH COORDINATORS MOM: s.. Mlim CMlranmanM AHMn Ntrod'tmiMi OtMnmwt -To'. nm Mr j Mr Owrm A*> j 1* w* p*t*m | swn r MO* am* IWM hmm Mrw* Am* nm TiImi Asbestos STS. Pleas* not* training requireaenta for affected eaployeea within 30 daya. \AJ-RN)ouMOy S A OuinoAes Croisup CQr dcoOvJ 0"f 0$i>6sJ4&9s ip ip QjbLoM 'TTVjAftMC^^ " '^Werc/. JTnQddihc* --IUtp rf\f^i<a3uucid/?CJQt^L v'}f'*t'a* a<wilMJw?ow-kld, himi4 Qrc m Q ikt\. --*> ^jSkrncjQrd KlOjluam cu 4Aa*vu/"ftR "t*-/ ^^ `ho db^\ s ir^j SiA* Wu v5'4c ndcu\4 Joi 1-A^ W of- ai( f-bvss 'Mot' n^jjf ^ C<majuP ^suQo^cb a$to dccu^vifc S4i)f 4^*^ "' * r. \ Jfl UJ^U-r-, Cev^cii^i. , itr DU 028377 frtdiy Kevembar 4, iff) I Pvt VII Department of Labor Occupational Safety and Health Administration Occupational Exposure to AaNstes; Emergency Temporary standard a* jo ir/t DUP 0907277 DU 028378 rdfl Ragietse I Vat q. No. m / Triday. November L 1W3 / Raise and RtgeUtiona Vtl. CavtmeoMMtt Impact. Requireestate ef Exaeutiva Order UtfL tad ihe HtgaUlary FWuUfey' Aet the Proposal to sseeruia whether Mployare mull ta able ta comply *uh analysis under the JUguletwy Flexibility tha standard la a short period af baa. Act la required. OSHA ha* sat a leva! which * iiyk. M Tie Nelioaii Environmental Policy Act (NEPAI of 1M (U.1.C 4331 Cl sag.), (i implemented by Ute guidtliace (00 CFR Port MOO) of Ike Causal M Environmental Quality (CBQ). reqa** Out federal agencies hhii their regulatory tenon* 10 detsmurw if there Si a yoteiiftal tor a atfmfieaat impact oe the quality of the human tnvtroviani and. tf aeoteaary. ta prepare ta environmental trepaet statement to accordance with thaaa roquinaentraH COL NEPA rogulatlon* (a CFR Part It {Subpart ft 11.10 (a) (t)|) OSHA had determined that because of the emergency nature ef Ala standard. no environmental tmpeot ttalament wtU be perparod tor the ETft The eauru have held that NEPA daaa aet reeelre advance preparetion it ta environmental impact statement for an OCHA ETS {Dry Color Moaufoeurint Ataaealtaa v. US Oaaorunaat aflabor 44S FJd aa. 107 (trd Sr. 10731). OSHA erUl aaaaoa. however.`Hie envtronmental eOacta af the propoted permaaaai maniatioe at astasias. The mailt* af this etudy will be availabia for review andaemmeot prior to the taormgi oa the ptepeeed permeant ataadard aad erlll be as appropriate lews far dtoeutetan at the pebhe hearing. la the toltrta. OSHA weioaraM aey comment* on any environmental (facta that atphi occur at a result at puueinlaution af a rule ao aetatoe. Pursuaat to the suihenty ef Section KaXl ) of Executive Order 123ft OSHA hee not prtfared a Pr^ulatory Impact Anotysia of thia ETS. Prepomtioa at sueh an analysis was not ptocticabia for OSHA to parfarm m tone to Itaut this CIS to respond to the grave dangers fscad by ssbettat eapoeed wartan. OSHA. hawevar. to aaapletiag a Preliminary ftvyulatery impact Analyoia of the proposal ta tevtaa the permanent standard which wiO be mad* public at the time the proposal to paWtohad. The Reputetery naxiMHty AM require* an agency to prepare n Regulatory Flexibility Analysis aniy fie those rein far which a notice at proposed rulemaking to pabtototd. OSHA'i issuance at an ETS Isarstore to net covered by the Raguiatary Flexibility Act batons* the OWA Aat provides that cm bn toauad without vni. tssomhry'aod tapirsetiaa at ta ITS Tbs requirements at this uaeryancy tamper*ry siendard ate set out to a anw paragraph, f 1*10.1l(k(. They am ' amiisd ta addftlaaal provision* to the lusting tsbMtoi standard srbich OSHA asxsidtrs easential and faaaibia to protset tmpleyaet fra* tha pra danger mauittog frees ssbaraa expeaere mta OSHA can pranulgato more aoupmiiraaivt trritiaaa to insrrdana with aactiaa (b) at tha Act Tha malar changat to toe standard made by the RS am: (l)Tha new parmiaatbto upoeum tovah (3) wetoads at eoteplialter permitted to achievt tod new level: end (3) e regainment tor ton etuUtohmtat af oaiatog pregrama within 30 day*. The fallowing secdon diacutaea ton mnler provtotoon nf ton ETft tha naeaaaity tor todadtog thaaa pmvtsiae* la toe ETft and earn additional prevtsfeM ta trigger eanala lequiremeau at ton redoond pnmsaatoto torn! atM f/os. l. fataarap/i MU Seam- An part at tot CTft OSHA in adding nnenaraph an too eeepa af too standard.The paragraph us tottsded la mtha daaa tost tha smatgtney standard applies ta all wetfcpUcM wham employees may in tapered to aabaetas to au todutfrian oavemd by toe sum* aabeston standard to. ganaral todaatry. 3. Jantfrae/i (*ffl PtrouaiibM krai bo achlavad tamadiataiy. uaiag quipawnt end eontml tachaiqua tost are currently available. S*d OSHA bottom, based an tha date |nanlad by OSHA't eaotmeur. Rnaesrch THaagto toatitata. that aamt worbpiaotc. aapadnlly In toe anufectiaisf sector, may ta daaa ta achieving abb t/ac leva! through tha mam rigeroue uaa af aacttearu* amtmto. urnrk pncsfme tad haeiahaapiag mathoda which am aow in place. OCHA easeunits employers to ooabaaa toair tfferta to Implement torse metonde to erdar ta smuts that tor tha toag tern, toe moat eampretaneive aad effsetiva pmtoaa af pretacUaa boa eatactaa txpaaura will ta provided. Third. OtHA taRaves that leliabOity af too cwmatly mqtdmd astasias sdiumflcnt matbods to aaaium aabaataa aspaatno toes than OJ 1/ee should ta open far dlscaatiaa dunng a mlamaktoghaarinp mthar than impeMd toroegh an ETft OSHA has totrefamaet adapted tha <L1 Vat tovti patitleoad by too mdana but toataad it aoMldariag adding provttnstothe astamos standard that any toaprava the mltobdhy af bedt aangtoag aad analysto to ton tofto) rutoankiM forma pwmanaat ataadard aad that aftaw tower tovele ta baMfiahiytoaaaaiod. EAjrapep* MV MuMt tf aamfSaaea. Tta CIS adds a now pwnspeoh OOOL svhia* pamtia saplayare to mdeaa toapunniisihia oftxptewe. As part of toe ETft OSHA is adding psrtmopb K*1 svhiab seta a new PEL eftoettvt totowdiatafy. afOto tf ac an an I bear ante weighing averepa taain. This rodeoed weal any bn etootve Istot ftoa toe otoieat 3 f/ce total to the an flat Kail by aey feasible aambtoattoa of tppmaerfag eontrail, srark paclicat aad mtpimtety pmtoniam Tha caweni leqtawmani in Mhtoeed by any (aestote aeabtaaUoa St tagtoacnag aeaueie. srar* pmaWaai aad roepintery protactioa to ardor to aSaw amptoynte ta toatttuta eflactnm aaaaama to teduaa tmptoyoe expatarea paro^aphs (eXl) and {cK3t to feat etotoa anpiinrieg caetrais aad werh pracOean to mdaet expoaum tovale la U t/e teesalaa amaflactod by thu ETS. Flexibility In ahaaetog aaatoliaaca atmttgiea toe too pariocaf cn ETS hat, OSHAahaaadif/aaaa too aenaintibltexpaturobvei primarily betawas U believe* toot mdudnp itogfayn mpcaweetaPd t/ec toafl ' todeatnes wig gmatlymdaan too fish af - boon innorpurotod to toast other previously taeaad emergency ttandards. 3ha paliey mftocai OVtA's dmertofaattoo to craft amargancy otMdarda that am truly rospensne ta devatopmg aabaataa iaduMd toucan. mMigency aandibaaa and which Word prtotarCy hap eanaer. maaatoaliama and Immediately aveSahia protaedea to gasimtateitlnal caaorr. At tat out into# aftoctad waehare. discissiau on "prove danger* Md . Aerograph HUM) tatptoyaa "WofAtS*. too amatar ef hvea OSHA. fajhimouda and ffPtofpg. Tha ETS adds regard to nailcn, potato anmmer aad ether roqulmmmms to tha - Administrative Piecedwia Aet Tha proposal to revise the parmaaaut irbatios standard, however to suh(oct to the requirement* of the Raguiatary Flexibility Aet and OSHA will avalaats bthotmomay bo unvud tomugh m Mmadinsu mduetton at enpaawe so tl t/ac ia tubataattaL OSHA tine hettovae that totSAf/tt toval it apprapnate tot aavmi atoar reasaas First, hacausa at awargaacy standard mat bs toeeibte. end . a pertyaph ta the aataatas standard mquMag toe samlayar ta provide a Miaing pre^em edtoto 30 daye af oablicatton af d amargency standard far ail aaptoyeaa erhoaa axpasems tie maaaaably axpactad ta txcaad toe PEL af Ohf/ac wtOnret regard to tot use el J G3250 DUP 0907278 DU 028379 tighter / Vol. 44. No. m / Friday. Novatibar o, un / pda* ^ jUguiatiooa tlltt mptraiora. and t* iMurt that all tach mpiayea* participate in tha Broprvat tad mi Wormed af ipadfitd cattgorisa of Wcrmatiaa. OSKA eenaMan (hia pwfdoa la h* 'Mcataary" with!* tba rawing af section 1(e) of tha Acl to reduce tba gram danger faced by tab***** axponid amploywa. THa abatne* of a trading program raguimoiant (a tka naaaiaa standard hit baa* p*M*d eat at ana af Dm aariaa* dafltitndat af tba aamnt standard. OSHA ballam that pnrtidpation in m tdtguto traiaiag pray** U aaaantfai for tha grotaction af aaaniaytaa htcaas* aaat aaataaUva praviaiant taliit lha aetpii*yat a* an acbva participant Far tiaapla. mart* aatpiayaaa handling aabatutdapand on dhetta weak practicoa. Wlthon* training la oppJybg than wait practice*. aaplayta pratactiaa wntld ha fnadagaat*. Whan tha aaglayta play* a an paaaiva mb la hi* protection web aa atban angiaaartag coomb an raiiad an. trainiiig ia aba MaantiaL bacatM tba twgloini aim know lha toureta af wocfcpUce aohaatna coataminotian. and tba ktallh haaardt af aabaotaa tcpaoun. rahigiaa tf tha reduced PEL af OJ f/ac. rtOttr thta etuldplt* af tha previous 1 ll ee panniiaibl# limit Far Magda, approved air purifying naptratan Bag be used only whan aabaotaa aoncantrationa era oat txpaewd to auaad I f/ec (10 a tha PEL), lafan tha CTI. bnavaa the PGLwaa t f/ae. taeb raigiratara eauld ba aaad whan aabtatoo conemtribotu woald oat lava xcaedad B f/ee (10 o tba PEL af X f/eeL Similarly. powtrod air garifyisg mpinton ouy bo mod whan ecbeatos eoneaniraUoBo da aot taooad ICO Unto tha PB. which at tha aaw laval af OJf/ oe la to f/ac. Pnviavaiy. awgioym eould kav# tuad aaeh raaolntaao at eoeomtntioao tgtalOO f/ac. . It b Bkaly that tha rain taped of tha rednead Fli on napintar taoiea wdl bo b operation* and taduatria* arhan axgoaan bvtb an batwaan I f/ac tad f/ec Foraarfy, angbyaa* aqwaad hi thb nitg* aaoid aaa bad-weak air purifying naptratan: now thay ataat b* jmtacted by a aowtnd air pvt^iag nopiratar nr a Ml faotoiac* noginiar. ar day any aaa a oogpwd dr Authority aad kignfi Thia docaatant waa pngand under tha direction af Ihora* C. Aachiar. Ajiiatant Caontary af Labor for Oceupationoi Cafoty and Health. Ui Department af Labor. Coiudtution Avcntt*. NW. Waahingtan, DC lono. Punwat W Cactian* 0(b). 0(e). c) aid dg) of da Aol m CFR ifiaion b onwodod by odding a naw paragraph (l) aa aat faath halow. (CnaKHdaLKeiaaddi) Pub-Lr-oaa lut no. uon uo& taon a uac a o* Pan m. Pub. L B-oe. a gwt. (40 UXC SUb a Ob Pari 10)1: Sacnury tt Labar'a Oder NaP-Siant unou igwd ot WaabagtA OX. Uia lad day af AtiMtut Inman'*fAtaar. PART IttO--tAMDOOCS] taction wo.wm af Pan mo af Tin* a af the Cad* af Ftdtni Ragubtiona u kanby mended by adding a arw paragraph Qt) nadieg u MIom: ( tataiwoi imam. titsatiaa and t* kelp racegafet whan awgtnaartaaaonmb an at ogwatlag gragtrty. CwtaUdy whan btanahirpiag plays aataponiai role daoatoi. mttnctiao about boaeakaapiog . mathada. far eanteplo. kagaant vacaaoting. b aaaanttal Paabaga aaat fcnpariaaiy. whan aagiagaa pimtction dipaida agoa nagintor aat. OSHA'a aapwiaaoa ahawa that mining awplayaaa in tha ttaa. Itting and Ualtadona af inaginian b awaal in the tfftctfvanaa* of napintar ontactiea. Accardintiv thb raoniranant aooiie* where airbaeno 'ho'aaomHIdBiio. gig lifaSimiil IlgOUgM Id afaaad Cat/ tWiing^wdjjmjwMw to X firgnfii Wvttitiiipa during m Mfri Tba ITt naaim Wat Wgibla tguraWa af thaWith hcaada af a&adoabe displayed at lacatioM arhm ibhoana aonmdana af aabaataa Aon txcaad the mdaead aapoaxrt ItaM af gj f/a*. No agadfla M^VoVM R n^WfwHpil WV NWly paatad dating lha CIl. OSHA wtaka* to *kt at pncticabia u peadbb the ngtd potting afatatc. aapodaUy hi arwhpuoao whan Own ha* baaa petvtawoan iBcgiioaaaandhianM whan aabaataa aoneantntfaa* wan (orwarty btkrw the 10 f/oc PEL Xt Public PwtiibnlVia blanawd yanaw an ioaMad to booed punaoM to taction g(c| of tha Amend applies t* ail waahpiae** whan awgltyoaa may ba ngaitd to atbaotoo in oB iadaatria oovtnd by tb* Act Incbding. gnarol industry, oonotnictioo and mamtaa. Eaaogt to tha actwtt wadifled by thb mtrgiaey tanporary standard ail pravialaaa af I maiooi (3) hrudaihh hah iftxpoturt JjbelLbaw ttna--aiabt^ vn-- ana thereby cempiy with the d. Aa aol IdfU ill |Mil|fagh (kgO) tha tmglartr nai Warm (ha aagdayta af tha haalth aflaatt af aabaataa rtgaaanr tha rabtiaaaliig batwaan aabaataa and ataakitig w gawtadag hng caanrt tha operation* aagnaWg aaigngaaa M aabaataa flban and I attga ta Inittto aagaaaaa; tba gargaar. aronar aaa. fittwa hMmotiano and faniiatioao af wagWlna. and tiw eentanttafaldwaaavtaianaaf tba A ibari gmndiwd at iwolMB. ibnMgkMWdMMtnr anawriaw Sang (WmTkaCT aWrdaadLn*idaannaemwlaAppkalrata^wgUramnphki MM which (Iac mi miMpBirlaagMimc adctien la tha OS f/ac PEL. Uadaa iha m tha concentration eaMffi far vanoao kisdi af nagiraton an ataotit aarlttan data, vtawa and aigmants with naptet to the nvtaiam to Ow eabcataa ataadard aada by the RS. Tbaaa aoaueaat* meat b* getanark td n ar bafan lanaary A UM aid aaat to tha Daekot Officer. Dackai No. H-013C Occupationtl talaty b Haahh Adnbtianuac UX Dapaitnant of Uber. BO Caaatitutiao Atom. NW. Rem MBA Waakbgtaa. D.C BSA Hm data, triawa tod argunanta that an tubatriad ariH ba evaflabb far yabhe bagactiaa add copying at tha above addnaa. Al ttaaly written anboticetoan will ba awd* a pan af the raoord af lha pnooadatg. Uriaf tuMaruloacrRPwtmi Oeeapntional aalbty and haalth. Aabattea. Haahh. Emergency tatiporary aUndard. Canon. i paragraph (alaflbbi (1) Afathodh tfeomgihna with th wiyMty mmpamry itnndari Hotwithatandiag any atbar nouinmaao af thb aactiotL eoaagliaBc* with tha nOaeai anoaan haul af 04 f/ec ahall b* addend by say faatibb eombiiMtian af angui*ru>t eontnla. warh gnetiota. tad gananal pretaeuva agtdgowst and device*. (0) tughya hfirmtia and taming.--fO Aa toon aa oomhkJuii rr^fnifna.,1i7fm"lak*` tnattnita a ir'(f "- innlavaaa MM< Ij airtflgi* acnoantrabaaa af attaiioa eii of JG32S1 DUP 0907279 DU 028380 I'JtfW a e rc.r aggflffiga f.rrtr;. -4- 1983 ! *ufc nd Regulations 0.5 f/cc. without nrfM lp the H. J -gP'raifla.nd hil ...nr, k^r**" ..fagph fllfl) of this section. letftle .displsyed ( each location where pnieip.iiooin,ihe Drmrjm dJtne the ' aagatetaja^entctivt period of this o^S^J1 4. Itmporiry slsndsrd.T (ii) The employer thofl sssur* that eecli such employe* i* taforaod ai the following: _ (A) Hie heillh effects esoociotod with . ,MlKllM8lpniw*r . r^fTB ffll The relationship he.w^p s.Kee.n. tOU I etpirater/ Protection for AI room* Concentratloes * kmjUi . tTfl | in (inoifvrtiiig 1 ei^j uumi coiiid reotth in ren^ti *? ipd BeeeeMrv mr,i~-nyr ,|rni r minimi*! tgoeare including. e eppliceble. npneerm, controls. wore practices, _ respire tors. BousIeUke4eJa-mn.srTaTnTd pnQfpgnve KDkpitiposo jwnpaet--e ftwine teetructioni end limltotioeto at reopirstoro permuted bv the steward; Alrteru Concentration of Asses toe <Ttot> fct in excess of t Hat 00 X HL) *>' te excess of to f/ee 1 iOO I PU) fcemtrea tssj^irsteiel tenuis or slefle use sir *rtf/lef respirator fell fscepiece sir 9orif/i*f respirstar, or e pomorot sir purtf/tep restester IS A review of n the mvi.;^. hootiineo iq jfftn in ~ WRotpiratory pniietian Airing At 7S Notwithitin<ii&| fqy other requirement of this section, where reepiretore re used to echiev* the permissible exposure limit of 05 f/oc they shell be selected eccordise to Teble 1. W Womin tknt dttrinr th*JBXJb, edition to the requirements of . ArtsUr LMn tu f/cc X type *C* continuous ftea er pressure sound, tepplitd sir resetretor. ^ lespirstors specified for ktpn concentre:.on* ee used st tour concentret tons of aidestos. 7 *" - (Secs. ((b). t(el 1(c) end SC|J. Pub. L n-MO M Stst 1303. 1301. IMS. 1SOO VS.C tu. SS7; See. tor. Pub. L tl-M. U Sut.to(40 VSC 83* a OP Put m, Seaeterv of Libers Oder No. a(<Tntwin J 03222 DUP0907280 DU 028381 -N * - b* TO: OH COORDINATORS DATt 11/9/83 rnw: I. < M1CITJ fnvirwMwitti Attain NttMtMAIiMi* OtMlWMM MM Nmuma IM* - ML 007 Hr A* Ht tmt* mm >WM MM um SMWU Hr Twir ~T"3! Asbestos CTS. Plssss note training requirements for affected employees within 30 days. Vtfft n)qu Moy v5 ^ GUiflOAeS Crolsup b79 Cor* 9k (JjtJuciO^vi fc i^> ckcc^pvrj o DVP 0907281 Osi?tsS-/&^ J'V1"' 3Tn Gcid)4tjr Ao hfiauoidL 'fta Qilou8o6lcr ^w*+ Prom <Q lkiA. --i*> . b*.X<L; ySrkmdQrd AjWUu/^o Qs Axj C/ynjfcArn4tcu 6^ ' 4b, bee t'rtf'i Wu/ v3"4q rtdcu\J/ ^Os) V\ju u<r^ cf- <s.if l*bvsj AAcrt fyiurt ho L/W ^SaQO^ah <J>UJ ciccu^uvii: S^iiy -fncu^ qJm-- UJ^Ur-i derrfQiciL ) ii-r h^e a cepu . ^ ` JC327S u 028382 EMPLOYEE RELATIONS DEPARTMENT Wilmington, Delaware ivs 7?*- CXC.K.OW CC: R. R. Bonczek - Adm B. W. Karrh, MD B. W. Culpepper, MD J. G. Page, Jr. J. B. Crunk L. C. Schaller/Supervisors D. G. Windsor/Consultants Asbestos Issue Coord. Coma. 1983 November 10 SAFETY & FIRE PROTECTION DIV. y ASBESTOS EMERGENCY TEMPORARY STANDARD (ETS) Attached is a copy of the ETS with a Summary and Explanation by OSHA. These communications are straightforward and fairly lucid. Specific Comments Paragraph (k)(3), Methods of Compliance with emergency temporary standard. The requirements in this paragraph are very performance oriented as far as achieving the 0.5 f/ce PEL. Use of proper respirators without further study is acceptable. However, this paragraph does not erase the required hierarchy of compliance methods in (c) of the standard in order to achieve the 2.0f/cc level. Paragraph (k)(4), Employee information and training. The training recommendations in Engineering Standard S 4 I if used will satisfy the ETS requirement to "institute a training program" within the 30 day limit. The only detail not spelled out in S 4 T is (K)(4)(ii)(E)-"A review of all the provisions contained in 1910.1001 Paragraph (5) Respiratory Protection During the ETS. This paragraph established new lower levels of airborne asbestos (based on the 0.5 PEL) for use of various types of respirators - note Table I The result is that respirators with higher protection factors will have to be used in some exposure situations for which 1910.1001 allows a lower factor. For example, a single use air purifying mask was acceptable in an atmosphere containing up to 20f/cc. Under the ETS, this type of mask is acceptable only to 5f/cc, so its use will have to be discontinued in favor of a powered air purifying respirator, a full face purifying respirator or supplied air respirator for use in the 20f/cc atmosphere. Pl***e communicate your questions or comments to H. L. Adam, S&FP, phone 774-1902. A meeting before the end of November will be arranged if that appears appropriate. Let me know. hSO HLA:gic Attach. DUP 0907282 DU 028383 SUM Fvdoral Rogsr / Vol. 41. No. Zi$ / Friday. November . IW / Rules and Ratalarions VII. Environmental Impart. Requirements of Executive Ortiat 133TI. and iht Regulatory Flexibility Ad tha proposal to aacartain whether amploytrs mutt ba able to compl) with analyaia under tha Regulatory Flexibility thr standard lit a short period of nmi. Act is required. -OSHA has sat a level which n likely to The National Environmental Policy Vni. Sumcry tad Exp'sMllee af the ba achieved Immediately, using Act (NEPA) of IMP (U-Sfc 43J1 at seq.J. ETS equipment and control techniques that i imaismenltd by (he gludniirius (M CFR Pm 1900) of the Coeacil on Environmental QualityiCEQ). requiroe that federal agtncies men their regulatory action! la dtitrmina if than < pottotiai lor i ilgnifieant impact or the ovality of (ha human environment and. if aaeaaaary. to prapara aa RviranmantaJ impact aiatcatant In accordanca with thaaa raouiraaianta and DOC NEPA refutation (a CFR Part ISubpart I. it.to (a) (4)11 OSHA had determined that because of the amatfancy natara of tiue atandard. no environmental impact tatamant will bo parparad for the ETS. The esurti have hold that NEPA dean not reouim advance preparation af aa environmental impact atateatent far an OSHA ETS (Dry Color htanufoetunn$ Allocation v. VS Oopanmant of Labor 400 Fid 90.10P (3rd Cir. 1*731). OSHA will aaaaaa. nowevar. the rnvirorueantal effact! of the proposed pamaaaw regulation of aabeatoa. The remit! af this autdy will ba available far renew and oommsai priaa to Ota h*ene|* an the propotad permanent atandard and will ba aa appropriate taaoe far diaettaaiaa at the public haartaf. la the interna. OSHA waloomis any comment! on any environment!) effect! that mifht occur aa a mauit of promulgation of o ntia an sabotaa. Pateuant to die authority af Samian Ka)(t) of Executive Ordor USt OSHA hat not preoarod o Regulatory Impact Analyaia o: ETS. Praparabaa of ouch an analysis waa not praadaabie for OSHA to parform in time ta iaaue thia ETS to teapond to the pave danger* faced by aabaatoa exposed workers. OSHA. however, ta cotaplatiaf a Preliminary Regulatory impact Analyaia of the propoaal to roviao the patmanent are currtniiy available. Tb* requirement! af thia emergency latnporary atandard art tat Sul in a naw Paragraph. | itl0.tn|k).Tbay art limited to additional prevtatant to tho Stcaid. OSHA baltavai. band an tha data generated by OSHA'a contractor. Research Triangle Institute, that tome workplaces. especially tn the ixjatlng aabaatoa atandard which OSHA considers taaanuai and fusible to manufacturing most, may be dose to achieving a &l (/cc leva! through the protect employees from tha grave danger resulting from atbaato* exposure more rigeroua use af anginaanog oeouoJa. week practice* and util OSHA can prersulgite mara housekeeping methods which art now in eoatprebanaiet revxerona in accordance with taction 1(b) of tha Act Hia malar changes in die standard made by tha ETS art: (1) Tha saw parMambla exposure level: (J) method! of * compluaca permitted ta achieve the new level- end (3) a toquimMH for tha eitabliahaaat af Mining program* within 30 day*. The following lactKxt discuiau the mater prwtaion* of the ETS. tho aoestnty for mefadtag thaaa provnioaa in tha ETS. and aon* additional prastsfons to ttfgtr oartain requiramantt at tha reduced permissible leva! efOi (fee. 1. Poroatopb fkjft) f:<p* A* part of tha ETS. OSHA b adding a paragraph on tha aespa af tha standard. Tbs parepaph is knandad to make door that tha emergency standard applies food woatfUoH where amplaraea may b spaaed to ssfeaatoo in all fodutnu oovtrod by tha cunam aabeatoa standard ie. gmatroi industry, cosatreetiao and marttkee. X.Aar^ruph fk)fil Hmmibtt tooot ofexposure. Aa part af tha ITS. OSHA L addaag paragraph (&N31 which seta a new PEL affective ur. .tdiataiy. af OR f/ cc an ex ( hour time weighted enrage basis. Thia mdueod lovei My b achiavad by uy faaaulp combum*tan of angfooartng oonvroia. xrsrh praebau and respiratory preteettea in ardar t* allow smplaywa to kiattMa affoehn maasura* to radxaa ampfoyu axpoatan place. OSHA aneourages employer* to continue than efforts to unpitmtm thata methods in ardar to assure that, (or the long ttra. the matt comprehensive and effective program of preteetiae from aaboataa anpoauto will ba provided. Third. OSHA baffovet that reliability of tha currently required aabcetae measurement msthsds ta manure aaboataa exposure* leas than OJ f/ec should bo apon for discussion derm* a rulemaking hearing, rithar than Imposed through an ETS. OSHA has therefore not adopted the 01 l/ac lava! pentiesd by tha anions hut iaataad is oonsidemg adding proviaiana to the aabaatoa atandard that nay improve tha rehjMiiy af bath tampfing sad analyaia in the Mb) rulemaking for the pamanant standard and thaw allow |*war level* to ba luhnbiy mearand. i. Awpgroph ftJfJI Modiobt of MampfaencR. Tbo ETS add* a oaw paragraph (kXJ). which paruuu . sMfoyem te ruduo* tbo puraiaaibir a^aaare limit Mai tha arrest 2 f/cc limit ta tha U f/*e haiit by anrfooaibla aumhlnatlaa nfaaglnearing controls, werk pickets asd raapuatary prutoetiaa. The sarreot requkemant fn pangpuph* (chi I and (e|(2| to firm auhao engmaarisg eonmia and work practices to indues anpoaur* Irvela to tS f/at rmuaiM muffaettd by this ETS. Flexibility in chnaatsg eo*rpline* atandard which will bo made public at kirnedlately. anxtagwa far tlm patiod of aa ETS baa the time the propoaal ie publishad. The Regulatory Flexibility AA OSHA about 04 f/aaae the ' aarmiasihfo aupuura bnl pamarily -baoa teoarpamad In meat other previously iaauad aaieruency atandard* requiree on agency to prepare a Woma Ubalians thl rwhuring lie pokey rafUma OSHA'a Regulatory Flexibility Analyaia anly for ampfcywanpoourcaWAf/uhiaJ . dtitnaixatian woefi anwrgtncy those rules for which a notica af faduatnaa will peaky rodau the rtak af auadaida that aie auly mtpoaaivt to proposed rulemaking is ptibiahad. . davelapmi aaboatae iadueed cancan, mnargancy aondiflona and which afford OSHA'a iaauaaat af aa ETS dtertfore ie -prtetordy km* cancer. maeotnaiioma sad immediately avertable protection to not covered by the Ragviatsry gaattaintuatinai xaneer. Aa set aut ta tha affected xrarkart. Flexibility Act booarjra the OSHA Act discussionoa "gran danger" and 4. Aaroaaoph (kH4) SjnpJay** provide! that CTfa ba laauad without "baaafltt". tha number af iivaa OSHA Infortnotteo ond training The ETS adds regard ta nonce. paidla oaaairnt and btbtvea may ba sand through u a paragraph ta tha nsbaata* standard other rxqairemsMa hi tho Admmittrativa Pwaadara Act The Immediate reduction of exposure to U ffee is aubattntial. raqeinng thr aaqdayar ta providi a Muting program within 30 days of proposal to luviet the pmutanent OSHA also baiient that the Oh f/ec eabeatoa standard. however ta submet to leni is appropriate for several other tha requirements of lha Regulatory rtaaons First, bacause an ametgeocy publication of tho ateargancy standard for ail aeiplayaar whoso txposurrt are reatonabiy cxpactad ta axcetd thr PEL Flexibility Act and OSHA will evaluate atandard must ba faaaibla. and of 03 f/cc without regard to thr u*r of DUP 0907283 J . DU 028384 31. <0 F*d*ral Kemitter / Vp], 44 215 / Friday. November < 1983 / Rule* and Regulations Oi C/ec. without regard ts the eie of retpiratort and ahali luun ihair participation in dit program during th* effective period of tin* emergency paragraph ((111) of thii lection, legible ligne warning of the health haxarda of ibettoe thaU be provtded and diipieyed at each location where i.rbome concantratiofti of noeeioi fibari may axcaad OJ f/cc temporary iiendard. c (ii] Tit* employer ih*l ium thi tech tveh employe* i* ^formed of th* following: * TA1U I let* inter/ rratecttaa (A) Th* h**ith tffesa* eaeodeted with *>b**to* expoeurc For Airaern* Cancertrattoei if Aaaeaui . (B) Th* mlatioiiehtp between labenot *nd looking in producing lung eaneeft (Cl Th* nature of operation! which Alroere* Cancentratten could mil in txpoeur* to *>b**to* *nd ntonaery protietive mpi to aaniaut* tf uttat 1 ruai tmirriMtliritlr1 expoeuro taduding. * ipplicaWe. *ngtn*ri8g control!, work practice*, hat 1* exeat* at I f/ec 110 X Hi.) aautaaia *r iingta via nr purifying raipirater reapfratot*. bou**k*pmg and protective 1 i clothing: (D) Th* purpoi*. proper naa. fitting Inatniction* tnd limitation* of reipiratofa pemitted by th* atandard; ana (El A review of *11 th* proei*i*n* at ta tiust of 10 f/tc 1100 X >U) 6r#aur taa tt f/ca Fell facar.au air purifying raipiraur, gr a *Maria atr purifying re*, piratar x t/p* *C* cantiowMi fi* If Tlllirt OMtafl contained in 2*10.1001. (uoplia* air rtaptratar. (S) Rtspmtory protection during th* ETS. Notwith*tending ny other reguirenwat of thii lectio*. whet* 1 taiyiraur* taeclfia* far nig* cancantrattaaa a*/ a* atoo at retpirater* are u**d t* achieve th* mot cenceatratiea* at aaaouaa. perniuibl* axpoawt limit of 0-S f/ce they dial! be leiecttd according to Tablet. (0) Warm** tign* during th* ETS In (Secs atau atci atet toe aiai. rub. L ei-ea*. uj.c xui. noil for in invin at aeSiai.iiai.tsoa.tMO.ieeamUJ.Cau. Uheri Order Ne. -tt tu FX itmi! addition to die requirement* of U;Sac.tor.Pvk lfi<u ulut.aa(eo grnu uairLj.. i n i t DUE 0907284 JOC-65 2 DU 028385