Lorillard
Environmental Protection Integrated Risk Information System (Iris): Announcement of Availability of Background Paper
Fields
- Alias
- 87805575/87805580
- Master ID
- 87805364/5929
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- PUBL, OTHER PUBLICATION
- REGL, REGULATION
- Site
- G65
- Author (Organization)
- Federal Register
- Litigation
- Stmn/Produced
- Area
- SPEARS,ALEXANDER/OFFICE
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- EXTR, EXTRA
- Date Loaded
- 12 Feb 1999
- UCSF Legacy ID
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11490
Federal Register / Vol. 58, No. 36 / Thursday, February 25. 1993 / Notices
ENVIRONMENTAL PflOTEC7fON
(FRL-4560-dj
Inte9roted Rtsk Information Syst.ta
(1RIS)s Announcetnent of Avallebility of
t3ackground Paper
Aae>rCy: L1:S. Environmental Ptotection
Agency.
ACTtON: Notice; announcement of
avallobility of background paper on
IRiS. request for commenu on internal
reriyw. and ennounaement of
substancea schoduled for work group
, reviuw.
suatttArtr: The lntepJated Risk
lnformetion SYstarn (gtiS) is a Jata bese
uf the United StatMs Fltvtronrner.tal
PrMedinn Aqency (EPA) that contaiau
EPA scierttitic cunsensus posltions on
potential human health effects from
e.uvironmantel trontazninants. This
tlutice provides information and
rrquests infotYr:atius on IRiS for the
pu:poces of improving the system and
aadrssibg questions tngarding
inereased pear re4iew and publ.+_
participat;on.
This notice contains three
components. First, it announus the
availability of a background paper
de+c:ibing iR1S, its contents. and the
current proresses used by the two
Agoncy work groups rosponsible for
devrlaping the IRIS information.
.cecond. ii dtscussas an ARency activity
to nview IR1S proc«ssas. solirits
commants on this artirity, and
higTlights poutts in the cturent process
whare public inp~t is encoumgrd.
Tbird, lt anaounr.as a new process for
publication of a list of the substances
scheduled for IRIS work group review
and the solicitntion of pertinent data,
studies. and comr.tanu on thasa
substances. This list will appear in the
Federal Register every six montlu for
the nextsix-month period following its
publication. The list for March i to
December 31, 2993. is provided in tbis
notica. Subsequent lists will cover a six
month perio(L
OAhs: please submit written comments
by Apri112, 2993.
aot>rtTssittt: Please send comments, an
otiginal and one urbound copy. to: Iris
Quality Action Team. Attention: Ltnda
C. Ttutan. Room 3809H. Waterside Mall
(Rf)-6t9). U5F:PA, 401 M Street, SW.,
Washington. DC 20460.
For a copy of the IRIS Background
Pap.r t:onuet: IRIS User Support
(Staffed by Computer Sdenas
Corporation). USEPA. Environmental
Criteria and Assessment Office (MS-
i9o), 26 W. Martin Luther King Driw,
Cncinnoti. Olf 43268. Telaphone: (513)
b09-7254 Facsimite: (s13) 569-7l16.
FOR F1lt1'rNER ttitaOR"TtOM CONrAcT:
Linda G Tuxan. EPA IRIS Coordinator,
Office of Health and Environmental
Assessment (R.l}4a9). USF.pA, 403 l.K
Street. SW.. Washiagton. DC 20460,
Telephone: (202) 260-ti949 Fecstatt7e:
1202? 26a-0393.
suP9LttiExrARlr NtronNr.TtON:
Saeicground
IRIS is an EPA data b.s.. updated
mon.thlr. containing Agency consensus
sclanti6c positions on potential adverse
human health effecta that may rasult
ffant oxposun to environmental
oontaminants. Currently iR1S contains
health eff.cts infortetation on
apptox3mately $00 spedIIe substanoea.
Sfnoe IRIS was developed trt 1986 and
made avaiiable to the public la 1988. its
use by EPA and by the environmental
health community has grown
substantially. EPA uses the d.u base to
provide consistent risk information
across Ep.P. programs and the regions.
States, national and internstiorul
arganiutions. and other public and
private orgastirations involved with
as.+assing potential health hassrds of
exposure to a variety of environmental
contaminants use DiiS as a source for
EPA scientiHc opinion on the potential
effeas. EPA saes IRIS as a primary
mechanism for communicating
technical scienti6c informaUon 9g.
potential chronic human hedl~t-bazarda
to Agency risk assessors and to trained
outside users. The Agency's goal is that
1RLS contain high-quality human hoalth
information, besad on credible saence.
Availebilitr of liaeiground Paper
As one step in the ongoing
development of titfawidely used data
base. EPA Is reevaluating several aspects
of i1i1S. This evaluation. described
below (see lnternal Review of IIt1S and
Request for Comment). is beinll
conducted in a manner that reflects the
history, purposas, and goals that led to
the initia development of IRIS. This
review takes into consideration the
current processes used by the two
Agency sclentiflc work Foups
responsible for dewloptng the health
k.iard information in nLTS.
TAerefors. EPA bas develo d and Is
makin~ available an IRtS eac~rottnd
Pa er that eontains the eoat6xttnl
iniortnetion described above. For those
=ea.rally unfamiliar with the intent and
history of IRIS. this paperwill servm as
a primer for that infortnation. Far those
wlto are regular IRIS usas, tae pepet
details the current processes ussd to"
develop tlse health ~asard Information
on IRIS. especially regardin activities
of the work groups responsitie for
ISSUE 42
APPENDIX C
developing IRIS Information. Interested
parsoas are strongly encouraged to
obtain this paper as it provides
background inforrnation for this Federal
Register notice and helps to better
understand the context of the Agency's
interns] review of IItIS.
letteraal Ra.dew ofIR1S and Request for
Comment
As part of an Agenry -wide effort to
Improve the quality of science used to
evaluate and manage risks. and because
of growing tnterest In IR1S and its role
as a widely used resource throughout
the risk asaessatent and risk
management comntunity. EPA has
begun a review of processes by which
the information tn IRIS is developed
and taaintnined. Tba purposs of this
review is to seek ways to Improve how
iR1S information is developed and how
it Is being used by risk managers.
The Agency has taonvened a team to
address issues invoiving the quality of
information arsd service IRIS provides
tbose who use the system, both inside
and outside the Agency. The goal of tlte
taam is to study the entire IRS process.
from nomination of substances through
delivery of lnfornsation. The team has
been asked to provide a series of
recommendations to senior Agency
managers to improve quality, (ncluding
cortsideratioa of Incseased public
involvement and additionaPpeer review
and more ef5cient and timely processas.
To aehieve this goal. the taam may
address conceras that could include:
publie involvement, peer review.
limitations of IItIS information for rfsk
management decisions, and balancing '
the addition of new substances with
updates of existing Information. Issuas
related to the adequacy of resources
devoted to t2te system, itaptowd
efficiency and timeliness of the process
for adding and updating tfles, effective
mechanisnis for issue resolut3on, the
quality of and need for regulatory aaion
information and supplemental data,
outreach and training. and science and
methodologiul issues may also be
considered In the fuuste.
As a first step In the esora's effort.
EPA is focusing on two issues, public
involvemant and extornalpeot review.
Fcr the purposes of this effon. public
involvement is de5ned as opportisnities
for affected or Interested parties to have
aome level of input Into IRIS health
bazard infosutsuon. These groups or
Individuals can involve a broader
spectrura of participants than external
paer revlew. External pear review is
dofined as critical appnisal of Agency
products by indepen ed nt experts who
are peers of those who generate them.

Federal Register / Vol. 58. No. 36 / Thursday. February 25, 1993 / Notices 11491
,
Current practias for public
involvement and peer review are
desaibed in detail 1t+ter In this notice
and in the IRIS Background Paper.
respectively. Briefly, under eurrent
p.er-review procedures, the technical
bases for the oral reference dose.
Inhalation reference concent»tion. and
cancer information on IRIS undergo
various levels of internel pear review by
EPA sciantists fa:niliar with the
substance at Issue. In addition. many
undergo external peer review from
V ups ranging from the Agency's
ence Advisory Board and the Off(a
of Pesticide Programs's Science
Advisory Panel to specielly-eonvened
ptorreview panels and workshops. EPA
is secking ways to address concerns for
intzeased and irnproved publJe
involvement and exianal peer review.
The Agency wishes to identify
mechanisms that can involve qualified
outside scientists and m.mbers of tbe
public in improving the quality of
Information in )3tIS. while not uAdu)y
dolayin the process of adding critical
new infosnation to the data bass.
Because EPA is bound by statutory and
public mandates and schedu)es. the
Impact of increased public involvement
and peer review on ttise ability of EPA
work groups to develop the IRIS
Information and on the ability of the
data base iuelf to deliver the
1nlormation to EPA programs and
regions in a timely manner will also be
taken Into consideration by the taem.
In this notice. EPA requests comments
from the public on these two Issues. The
Agency requests infotmation from
interested persons on how and how
often they use IRIS infotmation and how
It affects their decision making. The
Agcnry also requests comaenu on the
following issues relating to peer review
and public involvement:
Peer Review-
1. Should decisions made by the EPA
work groups responsible for developing
the health hazard information on IItIS
have further peer-r.view by scientists
outside the Agency?
2. iNhat are the adventages and value
(to EPA, the regulated community. and
the public) of adopting an talunced
~eer-roview system for IRIS
iafortn.tion? What are the
disadvantages astd problems?
3. What kind of peer-review system
should the Agency consider In view of
the significanrstatutory , public
mandaias, resource and time cons6reinte
related to IRIS end its usast What
sped6c approach or m.chsaisats
should the Agency explora?
Public Involvement- 2. By sending a written Freedom of
i. As desaibed later in this notice. Informatlon request for the materials
EPA provides severai nurent you need to: )eralene Green. Freedom of
opportunities for public involvement Informetion Officer. A-]O1, USEPA. 401
and input Into 1RIS. Whatara the M Street. SW., Washington, DCxoe60,
advantages and disadvantages of Under EPA's Freedom of infortnation
developing further avenues for public Act procedures. there is no charge for
participation in the IRIS processes? duplication of the first 166 pages
2. What are spocific otFier requested. For deta;lod information on
opportunities for Improving the science co", call the Freedom of Information
and value of IRIS by involving the Ofria at 202-260-4048.
public? Cutrsnt Opportunities for Public
3. What should be the goals and Involvement in the IP.IS Process
objectives of furtaer public Involvement
given the significant statutory, public ts datailedin the companion piece to
mandates. resource and time consttaints this notice, the IRIS Background Paper,
related to IRIS and its users? Wbat there ue several points In the current
X afic approacb or mechanisms IRIS process where public input is
uld the Agency explore? encouraged.lR1S users are Invited to
The Agency would especially participate in the IRIS information
welwme suggestions from members of development process. Four aurent
the publia experienced in various forms methods for public involvement and
of eer review regarding bow we can input are listed below in a suggested
taiPor any peer review to assure hieruchieal order of use.'They are:m optimum use of srlentific
talwnt, both s, LRIS Sciensf f/c Canmcts
within and outside the Agency, and
availabl- resources in addressing the Since 1988, when IItIS was made
mostfmportant scientific issues reised. available to the public. the names and
Since the turn is in the process of telephone numbers of two EPA staff
gathering Infotmation that telates to who are the scientific contacts for a
public Involvement and peor review specific assessment have becn inciudod
issues. ootnments should be focused on on the data baso. The Agency believes
those areas. If parties submit comments that the Inclusion of Agency scientific
pertaining to issues other than those of contacts able to discuss the basis for the
public Involvement and peer nview. Agency's position is very irnportant.
they will be catalogued and reviewed These individuals play e major role in
when that issue Is taken up by the team, providing public aeeess to IRIS and
Other issues related to IR1S are expected provide a conduit for valued public
to be considered at a later time in 1993. amnomt.
While the Agency will continue to
2,1R15 Public Reodina Roorrt
accept informal comments as it
evaluates the IRIS processes, the most Another opportuaity for information
helpful comments will be those received access is a newlycreat.d IIt1S Public
within 4S days l:om date of this notice. Reading Room located in the library
P)ease direct written comments, an facility in the Andrew W. Breidenbach
original and one unbound copy, to the Research Center, U.S. EPA. 26 West
IRIS Quality Action Teun at the addrnsa Martin Luther King Drive. Cincinnati.
given In the beginning of this notioe. OH. which is scheduled to open in the
Public comments will be conaidered In Spring of 1993.
developin` options for improved The 1WS Public Reading Room has
processes for IRIS. EPA a,ill summarize inforraation related to substances on
and address the comments received in IR1S. It does not have copies of
a subsequent Federal Register notice. carrespondena submitted in nsponse
Materuk submitted to the Agency in to the Agency's request for oomments on
response to this request for comments the internal review of IRIS that was
on the Internal Review activity can be outlined above. To review those
Sasp.cted In the following two ways: wmments, follow the directions
1. In peison at the Office of Rewer¢h detailed in the Internal Review of IRIS
and Development (ORD). Public and Request for Coaueent section of
Informatiom Shelf, EPA Headquarters this notice.
IJbrary. 401 M Street SW.. Washington. Visitors will be able to review the
DC 20460. The EPA Headquarters documentation files for substances on
Library Is open from 10 a.m. to 4 p.m., IRIS. These files contain the background
Mondiy.thsflugh Friday except for and supporting material, including a
Federal bolidays. Requests for cop ies of synopsis of the scientific discussion
these materials cannot be handled by underlying the Rtl?s. RlCs. and
phone. If you have any questions about andnogenicity lnformation that ate on
the procedur+es for the EPA Library, call IRIS. The files also may indude the
202-260-3922. following: CRAVE and RfD/RfC Work
IG

11482 Federal Regfster / Vol. 58. No. 36 1'fbunday. Ftibruary 25. 2993 / Notfoee
Group meeting aotes,iWS printouts
with bibliographies, public information
submucsioas, conaspondence. aed
annotated literature s+arsbea. Fil.s for
substance assessments not yet oo the
svstota wi11 not be available for viewing.
' Individuals wishing to review the
documeatstion files for substancea on
IRIS should contact the Cincinnati office
to schedule in appointment Tha IR3S
Glea can be viewed by appotatntent
only. Appointments should be
sclieduled at least one week in advance
and inter,ested parsons should identily
the speci fic substances they wish to
review at that time. For mora
information on the IRIS Public Reading
Room or to make an appointment.
cantect I]t1S User Support (o ted by
Computer Scieneats Corpon oa) at (S13)
ss9-7254.
The IR1S Public Reading Room is oaly
a first stap in providing inctemed access
to IRIS processes. At this time, the
Agency is unable to respond to informal
reqursts for paper copies of the files. As
pan of the intemal review of IRIS
described prtaviously, the Agency is '
avaluating other means of inotissed
Fublic access.
J.1RlS It. jormatfon Submission DeA
The most imponant of :hv current
opportunities Is the IRIS Information
Submitsion Dask that was set up In
1Aaa when thoq data besa became
publicly available. The Desk staII
distribute submissions to the
appropriata Ag.n .ry offices for
subsequent use in the IRIS inforuution
dovelaFment pr»cesses.
Tl:e most us+ful submissionsare
those received on substances that ara
scheduled for initial work group review
in tbe near future. This pesmits timely
and thorough review and corisideration
of a submission as an integral pan of the
work groups' scientilic deliberations.
EPA hopes that the list ofsubstanees
sclteduled for work group review'
wntained in this notice will prompt
submisrion of scientific comments and
annl)yix. stud!es, and id«ntification of
otiux pnrtinnnt st:i«ntific inftnrnation
from interested persons. New:tttdias
end other information on substances
already on IRLS are also welcomed.
Submissions to the IRIS Informatlon
auhnission Desl ere handlr:d in a three-
stap process:
First, interested persons should
simply provide s tist (subr.rssion
inventory) and briefly idrntafp all tAe
infnrmotion that they wish to submit to
the IRIS Information Submission Dask.
TSis submission imentory could
Include studiw. statistical anatysei ot
comments on data interpretation: If
appropriate. the materiels should be
listed using sdentitSedtation format,
that is, author(s)ti tide, lournal, and date.
The submittor will receive an
acknowl.dgemeot of receipt of the
submission inventory.
it Is important to note that iatetuted
persons should only intlude
information that they believe the
Agency would not otherwise have, such
as unpublisbed studies or other studies
not available through standard Utartture
searches. Published scientific literature
that Is readily identi5able and
obtainable should tiot be submitted to
the Desk; this Information ta gatbsred
during the standard work group review
process. The tu+ of the preliminary
submission ilventory will help preveat
an Influx of duplicative information.
The submiaston should includa:
A. A cover letter tlsat:
States that the correspondence is an
IiiIS Lnforntatiosl submission;
Describes in general tetms the
purpose of the sflhmission: and
Includes the names, addnsses, and
t«laphone numbers of persons to contact
for additional information on th,
submission.
B. A submission inwntory of all
materials tiut persons wish to submit
thu
IdeatiLes the substrtaos(s) by n.me
erd Qtemiul Abstracts Service ICAS)
numbdr(s). If the submission is not
relatod to a spuciCtc substan,c.e. but
related to in tssua(s) such as dosr
tits
response extrapolation methodse
should be clearly st.ted:
e States tAe section of IRIS (for
example, oral referenoe dose. Inhalation
reference concentration. inhalation
carcinogenicity assessment. etc.) that is
bwng addressed: and
Lists ar.d describe+ brietlr the
information or supporting documents
supested for consideration. ,
in the second step. FPA++(Il identify
from the submission inwntory the
inforraation that should be subruitt.d.
The submitter will receive notifuation
requesting submission of the selected
moterisl. If certain pieces of information
arr not requested for subtntssiorssn
explanation will be providaCto the
aender.
. in the third step. the submitter should
send incopies of the Information
requested by the Age/teq using the
following formst:
Submitters should send t#u.e
copies (at Lsst one of which shottldbe
unbound);
Submitters sbottld idencfy tAe
substance(s) by neme and t3enrid
Abstracts Service ICAS) numba(sr
Peraons submitting health elfects
data for substance fiJes already on IRIS
should include, fur each study
submitted,a specific explanation of bow
and why the study resuits could change
a quantitative risk.alue or relevant IAIS
narrative: and
parsons submitting haalth effects
data for tbcse sub.taacea scheduled for
consideration by the work groups
should Inclttde, for each study
subraitted. an axplanation of the
aigtsi5caace of the study results to a
potential RfD oe RfC, eetcinogen
useauaent wlna, ete.
Submittera aee cautioned t?sat:
Health etfaas data on substancas
subject to the reporting rules undar
Section !(d) of the Torlc Substsacs
Control Act (TSCA1 must be snbmitc.d
to the addt+oss given ia the rule.
Submitting them to tbe IItiSlnfarnation
Submiss;on Dask dou not relieve
pusons from an a(d) reporting,
roqufrotaant.
AU sttbtnissions are public
Jnfarmatiott.
Confidential Business Information
(GB!) should not be submitted to the
IRIS information Submission Desk. CBI
must be submitted to the epprvpriate
office via epptv.ed Agenryproccdures
for submission of C8I as codified in the
t:oda of Foderal Regulations 140 CFR.
Pan 2.-Subpart B).
lf a submitter believes that a f:9I
submission contains tnformation with
impliutions for J1t7Sit should be noted
in the cover letter accompanying the
submission. and
Any materials marked t.oafidentiai
will be immediately rarurned to the
submitter.
Once a submission has been evaluated
and approptiate work group review and
conclusions rstotded, a letter.rill be
seot to tha submitter, briefly describing
how the inforrnation was evaluated end
used.
Comaunts on Drinking Water Health
Advisories or regulatory summary
in formation will not be considered by
the 1R1S Infotznation Submission Desk
unless the commenter WentiAu an
inconsictonry between the Information
summarised in IRIS and the actual
USF'A Office of Drinking Water Health
Advisory or EPA regulatory Informatiort.
Questions aboutDriaking Water Health
Advisories should be addressed to the
Safe Drinking Water Hotline (1-80t)-
426-i791) or the other EPA contact
listed for that section on IRIS. Ahboagh
EPA regulations are sttmtnarized in
IRIS, letters- on the content of
rellations will not be considered by
thelRiS Information Submission Desk
they should be addressed to the EPA
program offica responsible for the
regulatory action. lnformatioa submissions should be
sent to:1RIS Infosrnation Submission

Federal Register I Vol. 58, No. 36 / Thursday. February 25. 1993 / Notices
Desk, USEPA. Env'ironmental tTiterta
and Assesstaent Office (MS-190), 26
Martin Luther King Drive, Cincinnati.
OH 45268.
4. Scientific Seminars
A fourth avenue for public Input into
development of EPA risk information is
to organize a scientific seminar with
scientisu from EPA. Requests for a
seminar can be originated either by
intuvsted outside scientists or by EPA
sciontists.
This is an opportunity for exchange of
Idoas on either a general ydenti5c issue
or on a substancespecific topic. '
However, tbase sdentific seminars may
not Include policy issua. Sciontifit
seminars have been used In the past to
examine new approaches to beal,t6
assessment and differences in data
interprvtation of key studies. Tbese
scientiGc discussions an Invaluable
during review of a substance.
Scientific seminars should be
coordinated with interaeted staff in all
appropriate program and research
offices.
Public Access to IR1S
Thare an currontly two means of
public access to the IRiS data base.
These are supported as official versions
of tRIS by the Agency. For further
information on these access tnethods.
pleue call IRIS User Support at;(513)
569-7254.
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1:TOXNBT
The primary method of access for the
pnvate sector b the ToXicology Date
NETwork (TOXNEi7. which is
maintained by the National Library of
Medicine (NLM), National Institutes of
Health. IRIS has been a component of
TOXNET since 1990.
TO3NE.Tis an on-line Integrated
system that is flexible in search, print,
and other commands. Users an easily
and quickly extract data either on entire
or selected portions of a specirud data
field. T0XNTT provides sophisticated
search and retrieval features for NLM
users.
iRlS on TO)cNET isupdated at the
begtnning of each moneL with new
information, modifications. deletions.
revisions, and notifiation of pending
actions, as needed. IRIS users cen gain
access to TO>24MC by direct call or
through several widely used
telecommuniutions networks. IRIS on
TOMET is also available through
NUd'a International Jr)mLhRS Centers.
For further information on gaining
access to IRIS via TOlP1E7. contact:
IRIS R.ptvsontative, Specialisad
Information Servicna Division. National
Library of Medicine. $600 Rockville
Pike, Bethesda, MD 20894. Telephona:
(302) 496-6531.
2. Notiono! Technicol lnformation
Service
IR1S is also available on high density
Sa/." floppy diskettes that may be
purchased from the National Tecbaical
31493
Information Service (NTIS). The files are
in ASCII format and are Intended for use
with a text editor. tRiS diskettes are
updated quarterly, while the IRIS data
base is updatad monthly:therofore.
NTIS diskettes will not always reflect
the most current IRIS information. For
infotmation on ordering IRIS diskettes,
contact: National Techniul Information
Service. US Department of Commerce.
5285 Port Royal Road, Springfield. VA
22161,Talophone:(703) 487-4650.
The order number for a single set of
diskettes is PSO1-3913]1: for e
quarterly subscription, the number is
P891-591330. Call (800) 553-b847 for
RUSH orders.
Work Group Substance Roview
Schedule and Data Solicitation
The following substances are
tentatively scheduled for review by EPA
work groups during the period from
March 1,1993 to December 32. 1903.
The list of substances includes those
that will be evaluated by the work
groups for the first time and those that
ars being revisited. In the list below naw
substances are designated by N and
revisits by R
To submit informntion to the IRIS
lnformation Submission D.sk, follow
the guidelines outlined pnviously.
Also. this list of substancas, with
appropriate updates tf necessary, is also
expected to be available on IRIS itself In
the near Futtue. Uyou have questions.
please call IRIS User Support at (513)
569-7254.
t:a5 Na
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Federal Register / Vol. 58, No. 36 / Thunday, February 25. 1993 1 Notices 11495
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