epa integrated risk information system program

7/29/2019 EPA Integrated Risk Information System Program

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EPA's Integrated Risk

InformationProgress Report and Reort to Cogress

U Envirometal Potecto Agecy: Ofce of Reseah ad Developet


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Integrated Risk Informaton SystemProgram Progress Report

I. Executive Summa

The .S nvronenal Poeion Agenys (PA) Inegaed sk Informaon Sysem (RIS) Pogram

provides healh effes infomaion on heas o hh he pbi may be eposed rovdng a

iial a of he senf fondaon for PAs desions o oe pbl i heah PA has ade

several hanges o hs moran Proga over e pas fe years seamining he assessmen

develoen oess, iproving anspaeny ad eang effiienies hin he Progam. n Ail

0 he Naiona Researh Con (NRC) ade severa reomendaions o PA for p roving he

develoen of IRIS assessens. The N RCs emmendaons ere fosed on he developen of

draf assessens and he NC as lea ha hir nen as no o de lay assessens

EPA has made progress in meenng hese eommendaons Conssen ih he adve of he

NC EPA is ipemening hese reomendaios sng a phased approah and s akng he os


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hase 2 EPA s addressg al l of he shoerm roenaos provde by e NRC As par of hs

ff A i ll mae several anges o R assessmens ghligs nlde evalaig anddesibing e seghs ad eaesses of rl sies in a more ufom ay ding oxiy

vales fo ipe effes assoiae h he hal f appiable an hee e aa alo;

ronely onsderng he use of ple daa ses of ombe ipe esponses ervg oxiy

vaes hee appopiae; an evaluaing exsng giees o esablsh eaer reia fo sy

seleon Phase of mpeenaio ll norprae e ongerer senf reoedaionsmae by he NRC

Te S Cogess has dreed PA o ssue a progress repor o he ose ad Seae Coees o

Appropriaios a eeva Cogressoal aog omees o esbe PAs mpeeaion

ofhe NRC reoendaios hs repo provds Cogess saeholes an he pbl i apdae o he RS Pogra ad PAs progress ard mpleeng e NRC reommeaons ad

ipovg he Poga


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I. Ioducton

The US vometal roteto Ageys A) Itegte Risk Ifomto System (IRIS) rogram

roves heth effets iormatio o hemils to hih the ubl my be eose rom eeases to

ai ter a through the use a sosa of hemas IRIS huma heth assessmets

rove ta r othe sieti fouatio o esios to rotet ubl heath aross PAs

rogms egios ue a ry o eviometal s RS ssessmets are ot regultios but

they ae ritl to Agey esios RIS ssessmets my ilue refeee oses reeee

oetratos ae sloe tors a hlat o uit rsks tht a be ombe th eosue

iomtio to hratee the ubl heth isks o heml substaes This iormtio s use by

EPA together th othe osertios to make rsk mgemet eisos uig regultios

RIS also is esoure or rsk assessos evrometl a heth oessoas i stte lolgovemets a othe outres

RS ssessmets ae seti reots tht rovie iomtio o a hemias h s el s

uatttive oseresose iomtio hese re eveoe rom the evalutio of reseh stues

o helth eets ombie th jugmets egaig ssues suh s rorite stuy hoieha raerto of efets uetty atos amog others Whe ombe th sefi

eosure iomtio EPAs ogram a egio oes stkeholers a use IRS assessmets


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igue ik Aemen k Managemen aaig aape fro e Naiona Reearh Coniparagm 98) The re box o e infoaion inle i IS aeen

R

Epi studie

Animal oxsdie

Asorpto,

Dibo

Mtbolism

xcrtion

Mhod

Expose

Hazad

Idetfao

os

Rspos

Amn

Exposre

Aessme

sk

Chraizo

Reulaory Option

Evaua pbic

hah, oom,soia, poiia

onseqenes of

- opto

Agy disios

and

Aapted fom th Nional Reseah oucl rslassssmn sk maagmnt aram (C 1983).

Beae of e ral imporane of RS for e Ageny an beyon a rong, via an enifiay

oun Proga key o proviing neee heah rk ifomaon Ove e pa o yea A a


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he ppoe o t poe epot to poe one taehode, d the pbi it a n

dte o the Prom d

E' owad memet e NR rcommendions.

epot poide a oeie o impovemn made to the ogrm oe he pat

ee ea th a n ema on t he mo eent mpovemen

II Th Consoldd Approprtos Ac, 2012

O eember 3 11 The Consodted Aproiton At " a sged nto he repot

langage nded deton to A fo the RIS Progm reted to eommendtios povided b the

Natonal Reseh Co (NRC) n ther reve of A draft RIS aesment fo fomaldehde. he

NRCs reommendatons povided n Chpter 7 thei ee report offered ggetions fo

mproig the develomet of IRIS assessments (see bes nd The reort lgge dies EPAto opote, s ap propate, based o hemia-peif dataet and bologial effe," the NRC

eommendaton into the IRIS proess he rept ngage so drets PA to nde

domettio in daft ssessments reesed fsal e desibing ho the NRC

reommendatios ee mplemented rthe, te reort angage dets PA to e a ogress

eort to the ose nd Senate Commttees on Apropratons and reevat Cogession athoizngommittees to desibe impementaton of the NC reommendation for ongong nd e RIS

assessments The fll eot lgage is roide in Aedx 1


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Fgur My 009 RS Assessen eveloe Process

Am Dvm P Nw IRIS

Intal Agecy Rvwd EPA Clr4ce

Fn.1 Assssmen

lgcyScic DUO

S o s m er f

$ H

lIRS$

TgRla,cmt


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PA wol anage he RIS Progra an ave na resonsibit or te conen o a RS

assessens The assessent eveloen ie was sorene to 2 onths a rection of oe han ha

te estae te for an assessent to be eveloe ne e revios rocess

Te nbe of ses n the assessent veloen ocess was rece fo 1 o ;

te feera agences an We Hose fces wol ave te oonit to ovie

scentc in a wo oints in he assessent eveloen rocess, an te coents wobe ae blc available

he assessen eveoent rocess wo ncle he ootnt or bl c coen an

re on an oen, rgoos an neenet exernal ee review

A bl c lisening session wo be ofee fo eac cheica assessent an

Changes n EPA's scientc gents rng he rocess wol be cea ocente an

exlane

EPA as eane srongl cote to scient integi blc nvoveen, rgoos neenen

exernal eer revew, an consaton wit scetsts at We ose oes an ote feeral

agences ortnies for bic involveen trogot te IRIS rocess incle:

bic nonatons of sbsances to be cnsee o an assessen o reassessent throgh

S


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V. Overview of Improvements fom May2009 to Aprl201

Sce e ew rocess was istte 2009 a as o te wrtg of is reo PA as comete

24 assessmes I scal ear 2009 PA comlee sx fia l IR S assesses after te ew rocess

was lemee I scal ear 200 PA colete 0 IRIS assessmes a reease e fo

exeral ee review a lic comme fisca ear 2011 PA comlee or assessets

cig e og-awae assessme or ticloroetee (TC) s fa isca ea 202 PA ascolete e fal RIS assessmets o cooeae earofa tetracooetlee (erc

a e o-cace assessmet fo iox PA rmais strogl comte to coia imrovg

e R S rogram ro a 2009 to Al 201 A

ae te oe o PA's ogra a egial ofices oaig a roritzig cecals

for assesset eveloe o esre at te IRS Pogam s resosive o e os cica

Agec ees

oste ega eetgs ewee e RS gra a PA's ogras a egios o iscss

iivia IRS assesses a e RS rocess

Creae a RIS logstcs team o el create re efciecies e assesse eveomerocess tis team s carge wi cooaig al amiisaive so reeig scietfic

staf o ocs o te sciece of te assessmets a


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ecommeto to impove IS ocuets geell A suy o the geerl ecoeios

i povided i be oe) (og-erm)

Tabl Nationa Rsach Counl ommndatons tat EPA s mplmntng n t sot-tm7

Geeral ecommendatios fo completig te IS oaldehyde assessmet that EPA wil adopt o all IRIS

assessmets (p 152)

1. To enhance the clarity of the document, the draft IRI ssessment needs riorous editin to reduce the volume of textsubstantialy and address redundancies and inconsistencies. Lon descriptions of particuar studies should be

repaced with informatve evdence tables When study detais are appropriate they could be provided inappendices Chapte 1 needs to be expanded to describe more ful the methods of the assessment incudin a descipton of

search stateies used to identiy studies with the excson and inclusion criteria articulated and a better desciptionofthe outcomes of the searches and clear descrptions of the wehtofevdence approaches used for the variousnon-cancer outcomes The committee emphaszes that it is not recommendin the additon of lon desciptions ofEAuidelines to the introduction, but rather cear concise statements of criteria used to exclude include, andadvance studies for derivation of the RfCs and unt ris estimates

tandardzed evidence tables for all heath outcomes need to be deveoped If there were appropriate tables, lon

text descriptions of studies could be moved to an appndix or deleted Al critical studies need to be thorouhly evaluated with standardized approaches that are clearly formulated and

based on the type of esearch, for example, observatinal epidemoloic o animal bioassays. The fndins of the

reviews miht be presented in tables to ensure tansparency

The rationales for the selection of the stdies that are advanced for consideation in calculatin the RCs and unit risks

need to be expanded All candidate RfCs should be evaluated toether with the aid of raphic dispays that

ncorporate selected information on attributes relevant to the database

6 trenthened, more interative, and more transparent discussions of weiht of evidence are needed. The discussions

would benet fom moe riorous and systematic covrae of the various determinants of weiht of evidence, such

as consistency

eeal udace o the Oveall ocess p. 164)


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16 Establish rtls r reie majr tyes studies, suh as eidemilg ad biassay.eetin tues f Deati efeene Value and Unt ik (p 65

17. stablish lear gudelies r study seleti.18 Baae stregths ad eakesses.19 eigh uma s exerimeta eidee.20 Determie hether mbiig estimates amg studies is arratedCalulat f eeree ae a Uit iss pp 656

21 Desribe ad justiy assumtis ad mdels used. This ste iludes reie dsimetry mdes ad theimliats the mdels r ueraity ars determiati ariate its dearture suh as

behmark dse, -bsered-aderse-ee leel, ad lest bseredaderseefe leel) ad assessmet the

aalyses that uderlie the ts deaure

22. Pride exaati the rsk-estimat mdelig resses r exame, a statstal r bilg mdel t t thedata) that are used t deel a uit risk estimate

23 rde adequate dumetati r usis ad stimati reeree alues ad uit risk ted by themmittee thrught the reset rer suiiet sr r lusis i the rmaldehyde dra IRIS

assessmet is e lakig Gie that th e deemet se IRIS assessmets ad their lusis ae

terest t may stakehlders, it is mrtat that the ride suiet reerees ad surtig dumetati

r their usis Detaled aedixes hih migh t be made aaiable y eletrialy, shuld be ridedhe arriate

8Tabe Naiona Ree Counl eommendton tat EPA mplementg te ongtem

Wegtene aluatin ytess iee aza entifiati p. 65

24. Reie use existig eight--eidee guidelies.

25 Stadardie arah t usig eight--eidee guielies26. Cdut agey rshs arahes t imlemetg eight--eidee guidelies.

27. Deel uirm aguage t desribe stregth edee aer ees

28 Exad ad harmize the arah r haraterii uertaity ad ariability


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to furthe mpove he RS Progra, oh as par o a ogog eo o segthe RS a also i

espose to the NR recommeatios At that te EPA aouce hat t woul impeme theNRC ecomeatos usig a phase approach As such, EPA is makg the mos etesive chages

o ocumes hat ae i the ealer seps o the ssesset eveopmet pocess Fo assessmes

hat are i he late stages o evelopme, PA is mpleeg the ecommeatos, as easle,

whout akig he assesses acwars to ea ler steps o the pocess Appe proves a gue

il lustratg the imig of plemeig Phases 1 , a 3 a a escripto of hese Phases s proveelow

Phase 1 o impeetato focuse o a suse o the shortte recoeatios, such as etg

a streamg ocumes, ceasg taspaecy a clarty a usg ore aes, gues a

appeces to preset ioaio a ata assesses Phase 1 aso focuse o assessmes

ear he e o the eveope process a close o al postg EPA s ow Phase o

ipemeato, whch aesses a l of he shortem recommeatios ro Tale PA s

ipeetg al l o these recoeatos ut ecogizes hat achievg ul a oust

mpeetatio o ceta ecommeatos wi ll e a evolvg pocess wih pu a feeack

fom the puc sakeholers, a eeral pee eview coees. PA w ll soo pulcly reease

wo a RS assessets tha repeset a ao avaceme i mpleeig the sho-er NRC

recomeaios (recommeatos fom ae Phase 3 o mpeetaio wl corporate he


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Sorter, ore cocie ad viua wt oe rap ad tabe ued to repree daa

learer ad oe apae wt repec t daa eod ad decio criteia ued

More rorouy eded to eae icoecie ad redudace

hee aeet alo w ll clude a eplae decrpto o te lterature earch approac ad

wil be iked o he ealt ad voetal Rearc lie ER databae to captue udy

forato ad reevat quaiatve data

Addtoaly tee aee wl

valuae ad decbe the treth ad weakee o crtca tudie a ore ufor way

cude toxcity value fo up le eect aocated wh te ceical i applcable ad were

tere ae uiabe epideiooic or expeietal ude availabe

ake ito accout te Hll crera aei evidece ro epdeoloica tude

Wei he epideooic ad expeetal ude peiet to each eect i a ore coie

ad eave ae ad ake a c lea taeet about the tret of the evidece for he

eect

rovide rapica preeato ta yteze reaed eect fro uipe ude

outely coder te ue of uipe data e or cobie ultple repoe i dev toxcy

value, were approprate


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PA alo evelopg gaphic ai that wil iltate the age o cocetrato evalate each

ty eee or qittve eet hi l l hep EA to ieiy cte o e ow or

gh eeece vale that ay be icotet wit the ager boy o lteratre

iay PA ha create Cemical Aeet Sport Team to oale a iteal poce to

pove atioa overal aty coto or the eveopet o IRIS aeet Thi iitiative e

a tea approach to makg tmely, cotet eo abot the evelopet o RIS aemet

acro te Progam hee tea wl l help ere that the eceary cplary epetie avaiable

whe eveopig rat aeet, a they wl provie a or or etyg a aeg key

e por to peer revew ee team alo wil l he lp PA obectvey moito proge

pleetg te NRC recoeatio o a aemetbyaemet bai A pat o Phae 3,

PA i evaatig etig weght-o-eviece apoace a wl aopt a approach o eveop a ew

approac to cotetly evaate weightoeviece R S aeet PA alo will ther wok to

evelop ytematc appoace to qatiy certaty a varato hee acto epo to the

og-ter ecommeatio i abe 2

he NRC ecogie that a ber o pat RS aeet eet ther epectatio reate to certa

ecommeato they povie or eample, teir repo evewg PA' ra RIS aemeto ormaeye, the NRC eoe a approac or preetg a ervg popoe RC vae that

wa e i the ecet IRS aeet otetacloroethyee a tchlooethylee otg that


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GAO s eviewed he d IRI ssessme disbuy phtle {DB), whh ws udegig

Agey evew e 2) whe A vded i AO, g h i ide ) desive d

pitl expts f he stdy selet etds sed; () tbes ht, g he tgs give

sde-by-sde pss stdies sdeed i detemiig e efeee dse f he

emil; d 3 bief desipts f te segs d weesses vis stdies sdeed"

GAO fuhe ted ht, f ese tw ssessmes, t ppes ht PA s beg ee he

edblty is ssessets by mg ges ht ppe be e wt he suggests mdeby he Ni Ademies"

ige 3 ilustes e spet PAs ets f Pse f mpleetg the RC

emmedis Ths ge pvdes ssessmespei fmt eted t stelig I

ssesses by devepig shte lee d e ise dmets wth eded vlume f

ext d gee se f ppedies pesetg et types f fmt

3 Pee ge be pges ee ssesses dig ppedes)

bewee p d s ee ves ssesses


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0%

%

10%5%

20%

2%

30%

3%4%

I Reon Inate

n ddt n t t tns dsibd bv, EA s dvd svrl iititivs tt r ky spts f

EAs s t fut rvig th RI rg Uss tws ntd ths iititivs t PAs rsns t t rdtis n Tbl


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T w du suu uds Executive Summary h gig f h ssss h

pvids is summy f h j lu s f h ssssm d hd d ds sps yss. ddily, wy dvlpd Peamble dsis h

mhds usd dvlp h ssssm Eh ssss will i lud imi lu

s sgy usd dvp dum s wll s h vu i d l usd

m diss u udg d xludig sdis i ssss ddl ds u h

Peamble d lu s sgy fud is VI B d C s p

s pt f h w du suu EP s giig mi dy f h ssssm i w

ss, Hazad Identcation d Dose-Response Analyss, p uh du vlu x

d dudis. Ifi l d pysil ppis d xikiis is g mvd

suppm is ppdx wih wil ipv h fw dum

I h Haad Idenficaon hp f h w dum p, E w us vd ls

ps ky sudy digs supp hw xgil hds dfid xpsu

sps ys wi ll usd s vsu ls i lysis is p w pvd

sghd d gd d sp disussi wgh vi l vid

suppg h fidigs ld 's hd d xiy EP ls is dvlpigsddzd sudy sumy s whih wil udd suppl mils ppds

ps m did sudy suy fm d ky sudy hsis


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Figure 4. Expose-response aray, Eteal Peer Revew Draf IS Tocooca evew of Bpheyl

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D-li span hihest to lowe es tst

ANOEL LOAE

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BDF, dY BDF dY BDF dY ma Male mal fm a fal f Wrt

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Spre-rat

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ain t Wstarrat Sprgu (7)4 Dawy at(1) (1 (1) 2 5

v> Body weih' Kdny' Uinay lade Devlopmentl

casd pls lvr nzys BDF mc.rasd by ght (>10% thn trs} BDF, mc.'Inc ids kdy lss lud: za in r lla BDF ; a plvs tnstion ll ylasaad sdi st in F344 ats y s ora Wisrrs a a ay alb as na tubur dltation Sp -aly ra"Isd dc ia bladd cal ss n yra in 3 rt an Wtar ratIra nur rs al s lta amas Wiss

1 ea e al., (2) lmal a 983 3 = Uda al 00 = hra a e al., 98; A al 6 6 =Cma 53 7 = Kr

Te Dos-Rspos Ayss seio of he ew doumen stuue ovdes le exlnio o te

tonle used o seet d dvne sudie o osidetion n ultng toxiy vlues ey d

suoing e dose-esonse nysis e eoed nd te mehodoogy nd deivton of oxity


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s llustted in Figue 5 he iee dvisoy od ), in e vw o te d doxi

yi notd ht g 43 nd n or sow ttiv omiso os t

RDs nd ek dose owe bouds ltd o te m nd idiologl studs

Ts igus e sful n undesdng te q itve sties.. i these lios.

gu 5 Refeene vue y fom 's 20 d Relyss o ey Issues eed to Diox

oxy d Resnse o oets

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10E7

B IRIS Aemet Preamble

e eview et e NR emmee t PA ex e 1 RI ssessmets


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P gdne nd e mehds d reri sed n deveg he ssessments. he erm "Pambl

d i e

iri r bigaplied across

ssessmens. The new Peamble ides dssss b he fwing tis:

Identiying nd seeing etent sdes

ving te qity f ndivid sdies

Weghg he ver evdene e efet

eeig stdies r dervt xiity vles

Dervng txiy vles

hese s resd t te five stes ht te NC detied i her eview e Elemes f

te key stes n te deveet drf ssessmet whi s swn n Figre 6 belw.

g 6 ements te ey ses te develet f dft R ssesset ige 7-2 teNRC eview e rldehyde)

[Excusion Crtera 1- - r LQuali I ncsset I1 di l Sues -J

Ws Idoce n an

riae fn


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strategies, sadadized sudy evalua critera ased he type study, the use f evidece taes

t suarze study detals stregteed ad mre tasparet dscsss f weig--evdece, ad

gaphcal dspays cadidae xicty vaues

Te Pabl will e cuded a ew I assesses as they ae eleased fr extea peer

review he Prab wll e dscussed a the s puic meetg te ew B pael tat w e

dedcaed t reviewig I assesses (addtal detals are prvided i eci VII F)

C Literature Search Strateg

's ew dcuet srucure icudes a detale descripti te terature seach sategy ad

sudy evauat prcess hat E uses develp I assesses Tis descipt, whc s par

ase 2 f s impeetai te NC ecmmedats, wi e cuded ew

assessets as ey are deveped discussg te ieratue seac strategy i I assessets

P wil descie hw te scieic lteaure wa gahered ad empasze w studies wee seeced

t e cuded te dcume ad, f appcale expai he atale fr excludig pteially

elevat studes fm he assessme. hs seci te ew dcuet strucure wil e specfic

each cecal assesse I is desged prvde eug fmat at a idepedet

lieratue seac wuld e ae eplicae te resus te eature search used y E i

devepig te assesset his sect, P wl l pvde a i t a exteal dataase


23/29

I cucig is aa lss a evelpg e sess EPA evaluaes e aa e

seg e easp ewee e expsue a espse a e pesece a se-espse eaisp

specifici f e espse cemical expse a wee e expsue pecees e efec;

csisec e assciai ewee e cemica expsue a espse; a

igca p lausii e espse efec a s elevace umas

EPA uses is weg evece appac ief e pea azas asscae wi cemica

expsue

EPA ecgzes e eei apg a fma weig--evece amew a iclues

saaie cassficai causa. As pa Pase 3 f mplemeig e NRC ecmmeais,

e Agec is paig a w cvee a wsp aapg weg--eviece pceues

eecs e a cace Te NRC iscusse cue appaces aza iecai wic

vves asweig e ues: Des e age cause e avese efec? [pp 159-160].e NC

ecmmee a e aswe is ues sul e a cea saeme e seg e

evece f causa, wig a saaize classficai avi amgui a esue

cmpaai amg fee ages a uces e NC fee as examples e uge

Geeas 00 ep smg a e mgaps f e eaia Agec f eseac
http:///reader/full/159-160].18http:///reader/full/159-160].18http:///reader/full/159-160].18http:///reader/full/159-160].18


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EPA w nier the mmen n un fm he wrp t eter p r pt exitng

pprhe t weigh--eviene fitn r ue in ubeuent ement ee

tvte repn emmentn 4-9 n ble 2

E Eal Pee Conuln

n itn t te publi tenng ein n publ i mmen peri t re l rey p te IR

ement evelpment pre EPA w nee te ue pub pee nultin wp

enhne te nput f he enifi mmunty emen re egne Thee whp wl be

pen t e publ wt pprtuny rl n writen mment nrmtin regng pei

pee nutn wrhp w be nnune the pubi in vne f the meeing trug

eer Regte Nie n n he webte Whe n n expliy te

remmenin e RC in he fmey review eprt, ery peer nutin wrhp fitwh the pri te RC verll grup emmentin he gl tee wrp wil vy

F exmpe he wrp my u n the tteteiene fr prtu hem r pvie

um fr iun wt expert bu eri -uing ientifi iue ht my mp the

evepmen ienifl ly mplex emn he fit tee pee nuttn wp w

fu n mue lung tum hey rete t umn ne ri hi n mpnt ue r te ement r nphhene yrene, n ethylbenene Ti wrhp wil be pen he publ ,

wt ppunty rl n wrtten mment t ntpe tt te wrp wll nvene n


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pbic ws ivited o povde wrte comets regrdg the sbject ter de dscsso PA s

g he come d reommedtos esg ro the wokshop, cdig he pbc

coets, to deveop drft cmtve ssesset fo six phthtes A coveed s peer

cosio wokshop fo diox 2009, hosg pb ic, threed, scieific workshop o discss

ke sses eted o dioxis oxict. he res of hs wokshop ifoed PA's deveopme of

PA's 200 d Resis of Ke sses Ree to Dioxi oxicit d Respose o NAS Coets

F. edcate Chemical Assessment Avisory Committee

Whe he NRC focsed he ir ecommedtos excsve o the deveope of drf IRS

ssessmets d did ot specfic ddress pee eview PA s seekg to ke soe chges i his

e to frher iprove RIS Specfic PA hs esbished dedcted Chec Assesse

Advisor Commitee der he spices of A Sciece Advsor Bod (SAB to provide dvce to

PA o drft RIS Toxicoogic Reviews d the RIS Pogm I ovember 201 PA oced

eest fo the pbic to omite potet peiss for ew stdg dvsor pe cdig

experts i he feds of pbic heth, epideoog toxcoog, odeg bioststcs, d rsk

ssessmet he SAB w ke pbic come o he proposed oed pe befoe ssembg

the f Chec Assessmet Adviso Cotee.

PA w sed he first ssesse o the ew co tee fo costto s soo s t s esbished


26/29

Thee aeme epeet a ao adaemet o te RS Poam pleet te R

eomdao

VII Concluson

PA IRIS Poa pode ally mpoa eath efe fomao o hea to wh he

pl may e expoed o eleae to a, wae, ad lad ad to he e ad dpoa o

emal IRS aeme ae al to aeo ad deo-ae at PA ad eyod PA

oad of Sef Coelo (BOSC) a eewed he RS Poa o eeal oao Tey hae

eozed e poae ad qay o the IRS Poa, ot that he RIS wee eee ao

8 l o t aa lly, a etaet to he a le of R S a a eoe" ad ta hat "he

opeheee, tapaey, ad otey othe RIS appoa hae made t to the

eatoally eoed tadad hazad haaezato"

PA eoze ad emae h ole ad dead ha a o, etfay oo RIS

Poa o tal mpoae. Oe the pat two yea, PA a woed o tethe ad

teame he RIS Poam mpo tapaey ad ea he e o fa aemeadded to he RS dataae wle aa a ome to pl eaee ad oo

expet pee eew Coay po he RS Poa a poty o the Aey PA wl


27/29

pi 1. Language rom te "Cosoldated Appropiations Act 2012" epo laguage2

ntegrated Rsk nformation System (IRS} n le of the directives contaed H Rept 112-15

regardng the Integrated Rs nomato Syste, the conferees agree to te olowg:

(1) Fudameta mpovemets to the pocis and pactices o ths program are ecessay to

esue tat IRIS assessment efec the ghest stadard of scietific tegrty

(2) Te Agecy sal incorporate, as appropri ate, based o chemcaspecic datasets and bologcal

eects, the ecommedatons o Chapter 7 o the Natioal Researc Couc l's Revew o the

Enviomenta Protecton Agecys Draf RS Assessment o Fomaldehyde into te IRIS

process

(3 Te Agency sa ll issue a progess eport to ouse and Senate Committees o Appopiations

and reevant Cogessioa authorg cmm ttees no later tha March , 202 descbg its

mplemetato of the Natioa Reseac Coucil's Capte 7 ecommendatios or ogog

and new assessmets

4 For dat assessments eeased scal ya 2012, the Agency sa ll include documetato

descrbg ow the Chapte 7 ecommenatons of the Natioa Academy o Sciece NAS have

bee mpemented or addressed includng a expaaton for wy ceain recommedations

wee ot copoated


28/29

review wl be oen b N fom a repeenaonal amle of IR aeen and N w ll

nt

Cngrss dcly of hs chocs.6 ) urer e oeee ongl beleve an uren and ue RI aeme o onl

be gounded n ond objeive and pee-evewed ee ad eodologe bu old ao

ovde rk manager w real vae a wl rel n en aned roeion of a

ea


29/29

Apedix 2. Tml for Phass 1, 3 of mlmtg th NRC commaos o IRS

Phas of implemntc NRC odao r IRS1

201:Re&e N'

J 2011 ISPus ,aniO adSICrm; fn U!

met

a A qw. TlR8I!in ad u etm;j 'nJ Nt

eyase PA'emti Cea 1ew No\yodo is uedsdrz rml lpc omt ane pr evF

Aet Rtela- l!Pl hKb-hiJ sf h p tn (,neleee Cr.

lhIUOT azsbimer rJ

tu,e iteo M

wh f dcws

Hvto

eVenc

wop

a 4"c eveoRae.

custle Noth1p S c.

epa integrated risk information system program

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