Document v6kEV1zqq2RxQnmQyBKvGdN8R
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DEPARTMENT OF HEALTH AND
st any time to conduct research to fill
of setenos. including risk assessment of
HUMAN SERVICES
identified data needs, until ATSDR
chemicals, thus creating a scientific base
Agency lor Toxic Substencee and DMene Registry
announces that research has been
initiated for a specific data need.
inMIftSf
amrtnr
far filling a breeder range of data needs
CERCXA. te section 104UX3XD*
,,
stetea that R is the sense of Canmn
[ATSOR-79]
Statue ot the Superfund SubstaneeSpeeffie Applied neeeerch Program
interested in volunteering to conduct* this type of research may write to Dr. William Cibulas, Chief. Research Implementation Brandi, Division of
that the cotes for conducting tab research program be bosns by thn MitMhwM and p r. in otilf
hazardous substtnese under the Tates
AGENCY: Agency far Toxic Substances and Disease Registry (ATSDR}, Public Health Service (PHSL Department of Health and Human Services (HHS).
Acnon: Notice.
summary: This notice provides the status of ATSDR's effort to fanpUmoi* the Agency's Substance-Spedfie Applied Research Program (SSARP). This research program, authcrtasd by the Comprehensive Environmental Response, Compensation, and liability Act (CTtCLA), aa amandad by the Suwrfunrt Am*pMwR*t awiI
Reautharization Act (SARA) (42 U.S.C 9804 (i)}. we* laltiatad on October 17, 1991. At that time, a hat of priority data seeds far 38 priority hazardous subotancaawss announced in the Federal Register (54 FR 52178). The list was subsequently revised besed on phH/ wBUMBti, mil published in
Toxicology. Agency far Toxic Substances andDisaase Registry,
Suhstenons Control Act (TSCA) and by mgiatxanta under the Pedate
MailstopE-29.1600 Clifton Road. NE*. Atlanta, Georgia 30333.
FOR FURTHOIM70RMATKM CONTACT: OK. William Gbulas, Chief. Research Implementation Branch. Division of Toxicology, Agency far Toxin . Substances and Diaaaaa Registry. Meilstop E-2S,1600 Qifton Road. NE.. Atlanta. Georgia 30333, telephone (404) 839-4308.
Insecticide. Fungirtafa. and Rodnatidde Act (PIFRAL ar by cote recovery front
peitiea nA.rCTCI A
aSad this statutory intent, ATSDR aisveloped a plan whereby ports of the SSARP will be conducted via regulatory
mechanisms (TSCA/FIFRA). private
actor voluntarism, and the dired use of CERCLA funds.
A Tri-Agency Superfund Applied Itsssarr.h.Committee (TASARC)
SUmSMOCTARY MFOMMTKM;
comprised of scientists faun ATSDR,
NIP. and tha EPA has bean set up to:
The Comprehensive Environmental. Response. Compensation, and Liability
(1) Advise on the assignment of prioritlae on mechanisme for filling date needs; (2) coordinate knowledge of
Act of 1980 (Supotfand) or GERCLA. aa ressarcb activities to avoid duplication
amended by the Superfund
' of research in other programs and under
AjMendmente end --iitWfaaHflq Am other authorities; (3) advise on Issues of
(SARA) [42 U.S.C. 9804(1)). requires that science related to substance-specific
ATSDR (1) faintly with the
data needs; and (4) maintain a
Envircnasrotal Protection Agency
scheduled forum that provides an
final farm on Novambor IS, 1992 (57 FR 54150).
The 38 snhetennpa. each of which Is found on ATSDR's list ofPriority Hazardous Substances'*' (56 FR 52188. October 17,1991). are iildrtn/dfeldrtn, arsenic, benzene, beryllium, cadmium,
(EPA). develop and prioritize a fiat of hazardous substances found at National
Priorities List (NPL) sites, (2) prepare toxicological pscJUee far these subatencas. ate Pleasure the initiation
oft research program to fill identified date needs assortsted with the
overall review of the ATSDR SSARP. Tba TASARC has met four times since
tha initiation of the SSARP. This notice provides the status of ATSDR's efforts to
onpfamant the SSARP. focussing on ongoing activities relevant to test rule development under TSCA/FIFRA.
carbon tstrachfori(fa. chfaroethsna. chloroform, chromium, cyanide, p,p*DDT.DDEJ3DD. di(2-
wbteaaoae.Jfafara starting enefc e
private sector voluntarism, and direct
program. ATSDR will consider
urn of CEROA funds. Additional date
mmibi.ii list ns nftle ls>nny * needs are being addressed through an
ethyIhexyl)phthalato. lead, marcury,
Testing Committee established andtar interagency agreement with NTP, by
methylene chloride, nickel,
section afe) of the Toxic Substencee
ATSDR's Great Lakes human health
polychlorinated biphenyl compounds Control Act cm the type of research that effects reaearch program, and other
(PCSs), polycyclic aromatic
should be dona.
__ ' .
Agency programs. To date. 99 priority
hydrocarbons (PAHs) (indudas IS ^ On October 17.1901, ATSDR
date needs associated with 35 ATSDR
substancaa), selenium,
announced the tofanrtfleatloo otthe
priority hazardous substancaa
tetrachkroetbykne, tohranau
priority data naetfa far 38 priority - -
(infhiding is PAHs) are being
hazardous subamncaa (58 FR 52178).
eddmesea via these mechanisms (Table
This nodoe alao sarvoa aa continuous call far vohmtary waaaich initiatives. ATSDR anooumgaa private ectcr organizations to volunteer to * conduct research to fill speclEc priority data needs. A Td-Agsncy Supernmd Applied Research Cncmrittee (TASARC) comprised of scientists horn ATSDR. the National Toxicology Program (NTP). and tha Environmental Protection
t research afiosta.
DAT8S: ATSDR constdara tha vohmtary research effort to be important to the continuing development oftil* SSARP. Thasefase, the Agmcy encourages private sector organizations tovolunteer
private i to conduct r march to fill spadfic
priority data needs. On Novambor 18.
1992. the Agency published a revised
list of 117 priority data needs far than
priority hazardous suhstancoa (57 FR
54150).
_____ _
Tha mafar goals of tha ATSDR SSARP
are: (l) To fill the subetance-roacifie
information needs of tha public and
idsntlflc community, ano-(2)tn sigplj information nacaaaary to mnrhirt -
comprehensive public health
iiMiiamtnti of populations faringnear
hazardous waste ritaa. This pragmas
also will pcovida dote that cm be generalized to otbsr substances or a
1).
A TSCA/FIFRA
In developing and implementing the
SSARP. ATSDR. NTP. and EPA have established procedures to identify priority date needs of mutual Interest to
Federal programs. These data needs will ba filled through a program of toxicological testing under TSCA. This portion of tba research will ba conducted according to established TSCA procedures and guidelines. This testing will falfill more than one Feden program's need. During FY1993. a Abate of the 117 priority date needs fa 38 substancaa (about 60) was ratened ti the EPA under its authorities following
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11435
review end endorsement by the
Currently, ATSDR la pursuing
minority citizens. The purposes of the
TASARC oversight committee.
voluntary research Interests with two
ATSDR-MHPF cooperative agreement
'unently. 28 priority date needs
private sector organizations: the General ere: (1) To initiate research to fill
uodated with 11ATSDR substances Electric Company (GE) and the
ATSDR-identified date needs for
have been recommended by EPA to be Halogenatad Solvents Industry Alliance priority hazardous substances, and (2) to
added to ita Master Testinglist, the fiat (HSIA). To data, through the voluntary ntw evisHeg disciplinary capacities
step in test rule development under
research efforts of GE and HSIA. four
to conduct research in environmental
TSCA, tection 4 (Table 2). Please note priority data naeds for two substances health at MHPF member institutions.
that although ATSDR has identified
are under discusafon. potentially
The areas of reaesrch st MHPF
priority data needs for oral exposure to leading to the signing of two
institutions include those related to
tetrachloroethylene. cyanide, and
memorandums of understanding (Table broad areas of toxicology and
beryllium, in response to otherFederal 3).
environmental health science. Some of
government agency needs. ATSDR will consider proposals to conduct
During FY1993, ATSDR staff members mat with officials bom (X to
the MHPF member institutions are mwdmUwg health studies of minority
inhalation studies in conjunction with discuss the Agency's research agenda
ooupe exposed to ATSDR's priority
pharmacokinetic studies for these
for PCBe. The Agency has identified
hazardous substances.
substances in lieu of bioassays using oral exposures. It is anticipated that
mutual interests in environmental fata testing and human health endpoints
D. National ToxicologyProgram
inhalation data derived bom these
assessments and has initiated
ATSDR maintains an interagency
i
studies csn be used, in conjunction with pharmacokinetic modeling, to address ATSDR's orel toxicity data needs.
Some of ATSDR's priority hazardous substances will not be added to EPA's Master Testing liat because they do not fall within the bounds of TSCA. Section 4 authority. For example, TSCA done
discussion on these studies with CE. ATSDR met with HSIA
representatives to discuss the use of physiologically-baaed pharmacokinetic
(PBPK) models to fill priority data needs for six volatile organic compounds. The
Agency selected methylene chloride to start using PBPK modeling to eddreee ATSDR's toxicity priority data needs
agreement (IAG) with NTP to conduct toxicological testing of substances identified at NPL sitae. The studies
determine levels ofexposure that present e significant risk to humane of acute, subacute, and chronic health ethcU. Often these studies include an
igaarment ofthe euhetance'e ability to cause cane*, reproductive toxicity, and
not require testing chemicals that are
because of ths extensive database on
birth dafacts. Too remits of these
out of production, such as PCBe. Furthermore. TSCA is not considered
the appropriate mechanism for tasting
this substance. The toxicity priority data studies are used by regulatory agencies
needa for the remaining 5 volatile
such ae the Food end Drug
organic compounds (carbon
Administration and the EPA various
PAHs, because tha PAHs ate by
tatrachlorida, chloroethane, chloroform, environmental and industrial groups,
products ofmultiple industrial
tetrachloroethylene. and
and ATSDR to improve tha ability to
processes and. therefore, it is difficult to trichloroethylene) may be addressed via conduct public health assessments at
identify specific manufacturers. In
similar voluntary efforts in tha faturs. NP1. sites. Under this agreement, one
addition. TSCA guidelines rat not available for some of the ATSDR
priority data needs such as the development of analytical methods for
C CERCLA-Fuaded Research (Minority Health Professions Foundation Research Program)
toxicity priority data need identified in .the SSARP (camm tetrachloride,
tanmunotoxiodogy battery of teats via
cadmium and beryllium, mechanistic
During FY 1802. ATSDR announced s eddiesesiLThis NTPstutlywas^egun
studies on the neuruUndc effects of leed. $4 million cooperative agreement
in September 1993 and should be
and tha mitigation of toxicity ofvinyl program with ths Minority Health
computed in February 1994.
chloride. Moreover, same ofthe ATSDR Prohetiona Foundation (MHPF) to
priority hazardous auhetencee ere
support subatanos-apecific
' B. CroatLakm Human Health Effects
considered more appropriate for FIFRA investigations. This cooperative venture Research Program
than TSCA, e.g.. arsenic, DDT, and
is supported bythe direct use of
Scow ofthe priority date needs
aldrin/dieldrin. The Office ofPollution, CERCLA binds. During FY 1993, shout identified in the SSARP have been
Prevention and Toxics (OPFT). EPA.
54 mtltiwi was allocated to continue
Independently identified as research
forwarded the data needs for theaa
this research program; no new projects needs through the ATSDR Great Lakes
substances to tha Office ofPesticide
wen initiated. Currently, 9 priority data human health efforts research program,
Programs for evaluation.
needs for 21 priority hazardous
a separate research nrogmm. To date. 12
B. Private Sector Voluntarism
substances (including IS PAHs) in the SSARP are being addressed by the
priority data needs tor 19 priority
hazardous
(including is
; As port oftbaSSARP, ATSDR
MHPF institutions through this
PAHs) identified in the SSARP are being
initially announced a sat of propoaed
program. Also, the MHPF research
addressed through this program. The
procedures for conducting voluntary
program will address 13 othar
institutions receiving awards and their
research on February 7,1992 (56 FK 4788). It was revised based on pubUc
sUbstanceepedfic data needa identified respective studies are listed in Table 5.
in tha ATSDR toxicological profiles
The Greet Lakaa Critical Programs Act
comments end published on November
exposures and related health of1990 mandates EPA. In ctmsuhatian
19, 1992 (97 FR 54100). This voluntary
: research program fills priority data needs along with othar mechanisms such attest rule developmsnt through
effects. The institutions receiving awards and thair respective rematch croiecta are listed in Table 4. *TfceMHPF. a not-for-profit 501(c)(3)
with ATSDR. to prepare a report by
September 30.1994, that assesses tbe advene efforts ofpollutants in ths Greet * musmRmmm M> ffa| hfUlth flf
EPA and CERQA-fundad research.
organization, is comprised of 11
individuals in the Greet Lakes states. A
Privata sactor otganiatlnns were
I tovohmtaerrto conduct miarcbto fillthese specific priority
minority health professions schools. Its primary mission is to research the persistent health problems that
variety ofperristent toodc substances are prevalent in theGraal Lakes. including Rat. DOT and Us metabolites, diridrin.
datanosds.
disproportionately plague poor and
tnxaphene, mlrex. mercury.
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Federal Register / VoL 59, No. 47 / Thursday, March 10, 1994 / Notices
benzoWpyrene, hexachlatobenzeae,
priority data need for 37 of the 39
consumer products, or occupation can
furens, dioxins, and lead. Certain
priority substances (Table 1). ATSDR
be used to design a rigorous analytic
populations--Native Americans, sport will obtain this information through
epidemiologic investigation.
anglers, fetuses and nursing infants of exposure and health effects studies, and Epidemiologic studies on several of
mothers who consume contaminated
through establishing and using
ATSDR's 38 priority hazardous
Great Lakes fish--have a potentially
substance-specific subregistries of
substances (sudt as DDT, PCBs. and
higher risk of long-term advene effects people within the Agency's National
PAHs) are being conducted by the
resulting from exposure to these
Exposure Registry who hive potentially ATSDR Great Lake* human health
contaminants.
been exposed to these substances.
effects research program (Table S).
The ATSDR-supported research
The list af 36 priority hazardoug
Two epidemiologic studies on lead
projects focus on these high-risk
substances in the SSARP was forwarded (identified as e data need by ATSDR).
populations to try to further define the to ATSDR'* Exposure and Disease human health consequences ofexposure Registry Branch (EDRB1, Division of
am also being conducted by the Morehouse School of Medicine end the
to these persistently toxic substances.
Health Studies, for consideration as
King/Drew Medical Center of the
The research activities include, but an potential candidates for fubregUtries of Charles R. Drew University of Medicine
not limited to: (1) Characterizing
exposed parsons, based on criteria
and Science via the ATSDR--MHPF
exposure determining tbs profiles and levels ofGreat Lakes mntemtp^
described in SORB'S 1988 document. "Polidaa and Procedures for
cooperative agreement ATSDR expects that other substaace-spedfic
in biological tissues and fluids in high* Establishing a National Registry of
epidemiologic studies, identified as data
risk populations; (2) identifying
Persons Exposed to Hazardous
neads or priority data needs in the
sensitive and specific human
Substances," To date, ATSDR has
SSARP, may potentially be conducted
reproductive/developmental end points selected benzene, chromium, and
by other Divisions within ATSDR.
and correlating them to exposure to Great Lakes contaminants; (3) determining the abort- and long-term riskfs) of advene health effects in
progeny whoso parents wen exposed to Gnat Lakes contaminants; (4) Investigating the feasibility of
establishing registries and surveillance cohorts in the Great Lakes region; and (5) eetahHahing a chemical mixtures database with emphasis an tissue and blood levels in order to identify new cohorts, conduct surreillaiice and
health effects studies, and establish registries and surveillance cohorts.
During FY1992, ATSDK announced a 52 million grant program to conduct
research on the import on human health of contaminated fish consumption in
trichloroethylene as primary
contaminants to establish subregistrias in the National Exposure Registry. However, aldrin/dieidrin, carbon tetrachloride, chloroethaaa. dtlorofoim.
cyanide, p.p'-DDT, DDE. ODD. di (2ethylhaxyl) nhthalate. mercury, methylene chloride, PAHs, aeVenhim, tetrachloroetbykna, and vtayfcafctarii| remain as a part ofthe rantHuma poof They will be considered for selection as primary contaminants during each selection process (Table 1). Finally, arsenic, beryllium, cadmium, lean,
nickel. PCTa, toluene, and zinc an not considered to be in the pool of candidate substances for an exposure
registry at this time- This decision will
ATSDR acknowledges that the
conduct of epidemiologic studies to determine possible linkages between
exposure to hazardous substances and
human health effects may be
accomplished other than by Agency
programs, or under other ATSDRspanaotad auspices. Toward that end,
thp Agency encourages the private sector end other government programs
to use ATSDR's priority data needs to plan research activities to identify
appropriate populations and conduct studies addressing the specific human
health issues.
Finally, the collection, evaluation,
and interpretation of data from
mmimiiImuiI
around hazardous
the Gnat Lakes region. OB September be re-eveluatsd as more infonnation on waste sitss have bean identified as
30.1992, ATSDR
nine
awards under this nromm.
the chemicals and exposure sites . becoms available.
priority date needs far all 38 priority hazardous aubstancea by ATSDR.
InFY 1993, aboittilnSioB was
With regard to epidemiologic studies However, the Agency realizes that a lot
allocated to support the continuation of ATSDR believes that for many of the 38 ofinformation has already been
the research projects conducted at the priority hazardous substances, an
collected through individual state
nine institutions originally funded
extensive amount of animal data, and
programs tod the EPA's CERCLA
during FY 1992. In addition, ATSDR
some human data, have already bean
activities: therefore. ATSDR will
awarded one now grant to the Michigan collected; therefore. ATSDR ccnsidara tt evaluate dm extant infonnation from
Department ofPublic Healthto deeim. appropriate, where feasible, to conduct theea programs in order to help fill data
establish, and operate a professionally epidemiologic studies on sudt
needs on substance-specific exposures.
creditable intaruboretary quality aisurance/quallty control program far the ATSDR Gnat Lakes human health effects research program.
F. Other ATSDR Pngmm
In its role tea public health agency
ftddnniBg
h--
ATSDR may, when appropriate, collect
human data to validate annetanoe-
substances. In response to public comments, the Agency's SSARP will address substance sparifie rathat then site-specific epidemiologic studies.
The substance-specificstudies are
tfariqwA tn <hnmhe mhetarae.
specific cense and affect. In this case,
ATSDR is not necessarily dfrectad toward populations exposed via the environment at hazardous substance
The results of the research conducted via the SSARP will be used for public health saesstmants and torsas*see ATSDR'* substance specific priority data needs. The Agency expects to re evaluate tbs priority data needs for priority hazardoue substancss svery three yean.
Dated: Mncb 1,1894.
release sites, as in a site-specific study. WatarB.Dewdh>
information on levels of contaminant* in humans has bean identified as a
Instead, any sppropriate population of DeputyAdministrator. Agency/br Taade suitable exposure via the environment. Substancss andPfseose Repttry.
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11437
Table 1.-Substance-Specific Priority Data needs Currently being Addressed Under ATSDFTs applied Research programs
Substance
y Arsenic
Priority Data Need
Addressed
1A Marhenirtc rtxles on tie narxotaxic sheets ot teed
IB Analytical methods ior tleaue levele
1C Exposure tovela in humane flying near hazardous wasta eitas and odwr populations, such
a* exposed workars.
2A Comparative toxacoMneSc Hides to determine I an appropriate animal spades can be
Mercury
2B HalMivee in surface water, groundwater----------------------------------------------------------------
2C BtoavaUabilty tram seS __________--_________ __________________________________
2D Exposure levels in humane Kina near hazardous waste sitae and other populations, such
Aft txpMid woricsfie
3A Mdgenareltanrepraduetiue toddy atixly via oral exposure________ 3B Ooaa naponae data In arlmais tor chrotvo-duation oral wmoetxa ___
3C Itnmunosoucotogy battery at taste wa oral exposure -
3D Exposuta levels to humane flvtaQ near hazardous waste arias and other popMattona. such
Viny! CMortde. Benzene
3E Potofdal eanddate tar subreplaSry ot er^oead persona
"
4A 4B
2
4C
4D
46
4F
__ aasapaaedwed--l
,
^
4
4G Potontaloanddato tor sutao^siryot exposed panona .
.......... .......
5A fines reepnnaa daaa in artraato tor ante and jrSawreilata itisdiiii oral exposure. The
aubdaerde study shod* Indude an etosndsd raproducKeorgan Naiopathotogy.
SB 2-apedsedevetopmantd toddy study via oral aepoaur*__
SC HiirnSiiiSiAijj iiatlatj it torts ~H r~al nprrrt
-
50 epomoiogai ruoii on uv wwi mni o* Dvomi i^piqb tn\pnM nponi
- dudorburaunototoc^r^
86 Bmmm ln^re fleevi Iemwmnmm fi^t^yreelmsse Ms^^^awsr Ietf^atrieai^Hriai^wa^sipK^P mOi ireAau^mp^p ^Mpwlr aM^^eflsd^^ds a^apu^ups^^u^a^e^are ^^aM^e^ekv
Cadmium
SA SB
fluids and atwbonmantol > sltoa and other poputaflona. such
PCBS
7A OoMn^onidtfihwiRMli tor rate- vtfintoniviflrtHkiilonQfikixpoMil ...........
7B Btodoqradaton al PCS* m water Wowtetehlty ot PC8i to tor, water ond ol -...............
7C OMKdMMMi iMi b Mbnit tar | MMMiMMlnfln finMOkn aamine^rep^fl^^^^^^Pdrevtiriwi^^^F
^^vtsan^Bs^e
usa^eas^^^ mMax re^s^^essi^pare^HB^^^a^BUP^H^H^si rere^^re^Ki^a^os ^w^^p^a^^^aOT^^^pe
in mbbiqk raoy mom vnnv vnMioiorabWGnf
7D gpMsmtdogfcal Hudee or the hedflr eriaett of PCSs (Special emphasis endpoints hduds:
liliBBWBa^rt QMRVMVOi sHMyi Pni raBnb^ w^OO VRwR|i la^wWMne^O^P
opmanlat toetdlyL
76 ERxoawe lavato In humane King near hazardous waala aflaa aid other poputaflona, such
Chlorolotm
BA owlhaJwalftatoctodctaototcrm(apacyamphaatoendpolntoln-
neuratoddty,. reproductive and davatopmantof toxicity, hapdctiwtly. and
ac
rend toddyX exposure texeto to humane King near hazardous waato dree and other popidaflrra. such
PAHs TTnilichnlfomniMtitny!wnt
so M
AC
o
96
9F 9G 10A IflB toe
too
Potwxtot canddeto tor eubreQtotry d exposedpersona ...... ......... ............ ............... fTnaa naapnnas itone n adnata tor mrannarlata rtaaflntr mal aipnaim The siduTmntr
atody ahetfld Indude extended rapreduetlva organ htatopathotogyand totmunepatootogy. BapeciaadavaiapmanBltoxfcflrabidyxtoWtolafloworctataRtofltw ----------------------MetfurtiUfc dudtasotr PAHs. on how mbttosaof PAHS can Influence toe utomata activa
flon at PAHa, and on how PAHa ailed rapfcly prdtarating tisanes. Doee-reapenae data to anbnato tor acute- and tatornedtato-dMIan inhatobon eremeurea.
Theattochronto etody should Inctuda extended reproductive orgac htotcpethnthfly and
Epjttoiejtotftattojtoe on toe hadto eftafls of PAHS (Speed amphasU andpolrfla Indude:
GwoHy OOfliUBp nnwjRi^ORi BnO I^^Kyr Exposure levala In humane Nno near hazardous mala dtoa and otoar pcptddtana, such
via the araf nxat. o teals vis toe and rauto Cptow'-vg < studtos on ths hsaltt dtods or tocNcraailiytans (Spaed antflxdhta toduda; cancer, hapatotoxfcfly, renal toddy, ttoMtopraarflal to natadodefly).
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Table i .-Substance-Specific Priority Data Needs Currently Being Adoressed Under ATSDFfs applied Research Programs--Continued
Substance DDT ...
Chromium...... ........ Tstnchtoroettiyiene
Atdrin/DMdrin . Cyanide
10
10E
HA 11B 11C 110
HE
11F 12A
12B 12C 120 12E
13A
138 13C
130 13E
13F 14A 148 14C
140 ISA
Carbon Tetrachloride BsryBum Toluene
158 ISC ISO
158 ISA
168 ISC 160
168 17A
1TB 17C
170 17E 17F
1BA
Priority Data Need
Addressed
Exposure levels In humans Wing near hazardous easts sites and other poputabons. such
as exposed anthem
Close retponsa data In animals lor chronic-duralion otsl exposure------------------------------ _
ComparsSva kuoooionetic study (across routoaftpedas)............................................. . --
Bloevailabaty and bioaocumulailon fcom sol
Epademotogicai studies on Ihe health effects ot DOT, OOP and DDE (Special emphasis
endpoints sidudec immunotujuclly, reprodudfae and dsvsioptnsmsl toxicity).
Exposure levels In humane living near hazardous waste sites and other pofXJtations, such as exposed workers.
Potential canddata lor subragisby ol exposed parsons
Hose response data in aramd* tar acuta duration exposure to chromium (VI) and (III) via
otel exposure and tor Intomtadato-duraiion expoam to chromium (VI) vie oral exposure.
MuMgenerctlon reproductive toafctly study via otsl exposure to chromium pit) and (VI) -___
Immunotoxiuology battery ot tests Matting oral exposure to chromium (III) and (VI)
2-spedse developmental toxidty study vis oral axpoaus to chromkxn (111) snd (Vt)----------
Exposure levels In humans living near hazardous waste anas snd other populations, such
as exposed workers.
Ones response daia In animals tar acutodutHan end exposure, inckjdng neuropathology
and dsmesnar, and Immuncpalhology.
MWQSntflBQn ItpfQyUGM WJUCWy HIQf VI W WpOHII ................................................ .
OMhfttponM dM In tnimili kjf
onl wpomis indudn^
nturopathotogy snd dMumoTt ind inwunopidw!iloyy
2-tpctat divitapmirttl ttddly ttudji vto oral upom .......................-............................
fetpotura tovoli in humm Iving noor htartow mm ** olhor popiMtont, ouch
m txpotod wortcara.
PofeMiOfll cinddra fv lubfiQMy ol Mpoood poraooo
Doio-rpoM dMi in orlnttli tor Mramodtolt-dwallon ortf npocM CK-----W-.n.iLDinRt.i.y Wwl) W0M Exposure lave* in htxiwne Wing near hazardous waste shoo and ether populations, such
ot txpottd woffctra.
Pratntfll cancttto lof tuboptty of txpottd ptraont nose retporwe data in arSmata lor acuta- and inlamtotlila duration exposures via Inhere
son. me suxhrontc aany snoun steams sxtsnosd reprooucwrs organ ixosjparrxxugy
snd evaluation ot naurattahtortoiai snd nsropslhStAd endpoints-
2-species pf|*r7p,irw>*v*r toxidly study via oral axpoaura
..
Evaluation ol the anviranmantal Me of cyanide in adl Exposure levels In humans Bring near hazardous wa
1 and other poputaflons, such
aa exposed workers.
Potential canddcto lor subnsgialry d exposed persona Onsa response data In animals lor chronic oral exposure. The study should include ex
tended reproductive organ and nanwus tissue (and demeanor) hfatopathotogy.
Immunotoxioology ballsry ot toots via oral exposure
.----------- .....
HaMtoinsol Exposure levels In humans living nssr hazardous wests sitae and odisr popuMtona, such
_ aa exposed workers.
Potsndsi canddata lor subregislry ot axpooad parsons
Doss response data in arimeta lor acuta- and XSeimsdsta durstlan tahstaicn exposure*.
The subchronic study should include extended reproductive organ hlstopaihoiogy. 2-spadaa davslopmantal toxidty study via WtalaMnnatoaaum ___ _ _____ __
Ersrlwnntantsl lata in art? factors sltacdng &loivatt8|t in air
Mvym rntTOQs t otwTrwit tnwvfwntra
Wnunutoxlcology battery oI teats tottowlngonl
Expoaura levels In humans fving near hazardous waste sSsa and other populations, suclt
as argnsed workers. Pose response data in animals tor acuta- and mtemsrtata itsMton oral exposures. The
subchroric study should indutto an extended hMopatootogieal svakradon ot toe immune
*
*
*
188 Comparative taxicddnetic studtoa (Ctwractartzadon of absorption, datrtoutkn, and
Ion via oral axpoaura).
18C Naurotoxicoiogy battery ol teds via oral axposwa ...... ... ........................................ 180 Mcranvn 01 vnnnvHnouoKi nMiwBnf 18E EJtoosure lovals in humans Wing near hazardous waste aiaa and odier populations. such
m ttpoMd wortrara. 19A Epldamidoglcsl studtoa on ihe hsabh adada ot nfckst (Special emphasis antidote tnckida:
rapmrtirltva toxidty). 188 2-apetias davalopmstitsl toxicity study da Ihe ore) route 18C in antmata far acute-and totarmsdtali duration oral exposures
180 Nerxotasicology battery oltoata via oral exposes .--.-------------------------- ----
1*
of nickai trem sol.
--
18R 1 levels in humans faring near
dtae and other poptMtons, such
iic^oiidraiMfi
^
BfG40?i4
BFG 00209
Federal Register / VoL 59. No. 47 / Thursday, March 10. 1994 ) Notices
11439
Table i
Substance-Specific Priority Data Needs Currently Being addressed Under ATSOR's appueo Research programs--Continued
SubStMM
ID
P* mty n^>ikei
39
3C
Benzene
*-
>8A
III*
____
a&bnto*t& moult return mt*m&fq)m&Kb*gMMopaheloar.
SC
NetMtaMoag MNyMM*eeeratespoeuRB
. - ...............----------
10A -
Ctaomum
toe kHMSWMcology bsasry at tesa ts Mont mule
--.................... ...... .............
12A TTnn hi mm mu ti ------- ------------ "---------------r------- --1
risen* sepoeure.
12B ieetj.nie>wpwrtrthMtMtre^^teUeflteMMineelp.d--rtum (Hand (VQ,
12C TW1WMO1BW7IWI 1M.W 13A
fin-- riyrrii (Me A Manets tv scuts damns era* aspoeue. Muffle
-
138 MuMgenetMon reproduce** taafcdy sariy vie ant tec1*------------~-------------------
s 130
I-- dw^a>wa--l-w^
i 8^----
. .-------------
T3CAIHFRA
TSCA. TSCA. TSCA. TSCA. TSCA. `
TSCA. TSCA. TSCA. TSCA.
TSCA. TSCA. TSCA OnhaWtan study). TSCA (IrtaristtoA study). TSCA (InhsNBnn tfudjt).
BFG40715
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11440
Federal HtgiitB / Vol 59. No. 47 / Thursday. March 10. 1994 / Notices
Table 2.--PwoiRrrY Data needs Being Aooressed by EPA Rule Making--Continued
Substance Cyanida .
ID 15A
1SB
Betyfcun
--------------------------
ISC 17A
17B 17C 17E
Toluene ISA-------------------------------------------
188
Methylene Chloride---------------- 2QA
WtaOrOBuHlH IMMMM.M HWM
208 24A
Priority Data Need
TSCA/FIFRA
Dnee reiponaa data in animals tor acuta- and toMmwdtoteduNSton expoema via av
hatodon. The suhatwts study should include extended reproductive organ
histopaihology and avaluatton ct naurcbehavioral and nauropathctogical endpoints
2-Spades dswitopniantol toxicity study via oral exposure
.......... --....
Evaluation oi the environmental talt o< cyanida in soil ,,--------------------------------------------------------------------------
Ones raeponae data in arenaIs tor acuta- and totormsalsto duration inhalalion expo sures. The xubcnrorxc study snotid indude extended reproductive organ
nRBpiinOlQ^ft 9 tf trill rtfmlnpwmrmi towirHy
wm
......... .................................. -
ImmunotasicoICBy battery ot teats todowtog oral exposure------------------- ----------------------------------------------
Doaa-rasponaa <tota In animata lor Intermedtdeduislion oral expos*ree. The study should indudo wi trUt^Hd htoopdhologiotf tvoluotton of tht immunt lydon.
Comparative toxicoldnsttc studaa (Charectorteslion ol absorption. rtoMbudon, and exersdon da oral exposure).
Class raaponaa data In aidmala tor iraamiariato duration oral exposure. The study Mould Indudo uOfriol fcwnunopodwioqy ond nounjpdhology,
2-opoctao dovotopmofdd looddly tody >Ho tho oid nodi ...................... -.................. Doss issponss dtia in sntmals tor acuta- and Internedate itaaSon oral expeewee.
The tubchronic study should toduda sw svatoxion ot Sianuna and nervous system (and bahatdor. demeanor) itaauaa, tnb axtonded taptoduedvo otgsn htotopathdogy.
%' *
TSCA
TSCA (nxv- -in->-o n
siudyL TSCA. TSCA
TSCA. TSCA TSCA (XTw--m*----w1-T^1W----f-i study). TSCA
TSCA
TSCA
TSCA TSCA (EPA
wtoorSy address the
imrmmo system retirement of Ms Priority Data Need)
Table 3.--Priority Data Needs potentially being aooresseo by voluntary Research
Substance PTMe.................................
o
78 7E
Munyom cnonoi ............ 20A
208
Priority data need
Firm
Epldandotogtesl ttudias on toe health eflscte ot PC8a (Special am-
pniMO mpono rauom tWnunwDiOCBy* yoiiAnnwUt vmfi
MNT| Monoy.
OOCnjIs fldOQUCMVOMMOpnOfMR IDwCRjiB*
Ocm+mporm do in onimoli lor acute* ond irttorrwdotodundon
oral exposure. The subchronic study should toeksto extended ra-
pfOOUGM ofQin fwwpagwogy, nowopOTwgj mo ttenteww*
ond Immunopothdogy.
2 Md-- dovdopmomd taddty otudy do tm ord route-------- -----
General Etoebto Company. General Elect* Company.
IMogenMed Solvents Industry * Panes.
1 Isloginalsd Solvents industry Alienee.
Subdonoo Lead
Mercury
Table 4.--Priority Data needs being aooressed by mhpf institutions
Rrn^uurUlkyj CjSbMAa nn^fAiit8l
insdUtan
1A Machardslto stodas on th* naurcsoxfc effects oMaad _ Florida A 4 M Urdvonffy. Texas Sotdham UrMndy.
1C Erasure lavale to Humana Mng near hazardous The KtogfDraw Msdtoal Cantor ol too Charles R. waste sbee end other populations, such cs exposed Draw Unhandy ol Msdfcina and Setonee. Morahousa School ol Medtotoa.
SA MiragsnsraSon reproductive toxicity study toadar Tuskegee Unhandy.
PAHs
88A
90
Trtcnofoodiydno 108
2-specisa developmental totocHy study via oral expo- Xavtor Unhandy. aura.
Dose rsxponaa data h-anlmato tor totormaJMa dura Msherry Mtdtd CoSaga. tion oral exposures. The wtochrorVc study shoiid to-
ctoda extended reproductive organ Natopafthoiogy
and Immunopathology. Dose response data to animals tor acute- and meer- MMirty Mtdcte CotaQt.
midtots duration Inhalation exposures. The
aubehrenie stody shoidd toduda extended raproduoSva otgsn Nsxrwihnirigy end tostsstopsdwtogy. Neuretoxiootogy bedsry ot tost* vie oral expoeura -- Texas Soutoatn UtdvanKy.
ta
BFG40716
BFG 00211
Federal Register / Vol. 59, No. 47 / Thursday. March 10. 1994 / Notices
11441.
Table 4.--Priority Data Needs being addressed by MHPF Institutions--Continued
Substance
ID
riuiy (oSanSw avtiMA*Oai
mstRidcn
Toluene Zinc
1
tec 214.
DoiHiipQfsi ddi In Mndi lor icuii* md inncmiddHunttn dd ddomit. Thd tubdvonic WJJr anOUP mill > MinON iWWpBIwOJBII ivdudion of did toiwvjnotoQic md nmroiogicil syd*
lams.
Taxes Southern Unrvers*y. Xavier University. Tuskegse Univarssy.
table 5.--priority Data needs Being Addressed by the ATSDR Great lakes Human Health Effects Research Program
Substance Mercury > PCS*
PAHs
ID 1C
3A 3D
3E TA 7E
7F
BE
Priority data need
Instfcdon
Exposure levels In hunsns Mng State Univerdty ol New York at BulWo.
near hazardous waits sNsa end Stats University or New York at Oswego.
other popdadona. such as ex- Mkhigan Stats University.
pood wortwflfc
Unhsrslly ol IMaconsin--Stmsrtar. Nseaww Yr^warti Ssmtwmsw ivmra^pKii nirsxiijvismiiwMwi
unlvsrsey of nds at Chicago.
Unhsrslty or HnNs at Urbane-Champaign.
WWQOnMl POpMVIM OI nNmi Pw 9PsRPIi
MuMganendon rspndudhe toxicity Stats Unlvstsayol New Toth at Oswego.
shidy da oral amoaure.
UrtvenMy ot anois at Chicago.
Expoau*. levels In humans Mng Stats Urdrersky ol New York atBuHato.
near hazardous waste dtas and Stats University ot New York at Oswego.
other populations. such as ex
easR>H aw-W V- --I^--r- *-
posed workers.
1 awiiawtuoewMiieyi go^ei aireObMwsn^f^f_FA^rwaiaiwslwaa*
Ncv Tone mi nm wpmonL
umversky ol AMs at Chicago.
umvraypiMMpuisoMKinoi^dpi
WlKonam Oippinot of Hndi and 8mI SowtcMe
roww cwm Oi fuoiopsvy 01 mm upmini o* nom w ow 9Vtncvi>
OpONd pOfMMs Ooss-rssponse data In snimsls tor Urtvetskyol Wisconsin fliparlnr.
oral exposures. Bpawwopco uqm on mo noMn
enacts ol PC8e (special emphasis andpoMs tnduda: Immunctowklly. gaslrolntaitlnd tadcRy. Ivar, Hd> nRjfi UljfWO OwnRjFi tePwO^mWa davatopmantal taxkJlyV
Exposure lavats in. humans Mng near hazsrdotw waste sitsa and
Stats University oi New York at Bultdo. Stats UdvaraRy ol Now York at Oswego. Unhmtsty ol Wlaocnam--Superior. Untvarslty oi NMa at Chicago. University ol Mnoie at UrtaaneOwmpaign.
State UnivereRyol New York at BuRslo. Stats University ol New York at Oawsgc.
powdiwteHv
i
IWx --fW*- --O---fMtx.jf- OV nHOnH_^__WA.^p^^^iSngw^Ar' New York State Health DapidnanL
UnhersRy el Mnoie at Chicago.
Udveraky ol Mnoie at Urbane-Champaign.
WNOonnn uopvwnovv niMi wmoo 9irnM>
onthehaattt Wdoonam Department d Heaflhand Social Sorvkoe.
i Indudr cancer, dermal. hamoiymphaHp. and hspaik). BP ' In humans Bring Wisconsin Department ol Hoaklt and SocW Sorvicee.
DOT
110 11E IIP.
odMf popiMontg wch m ir> poiidwortofi Epidemiological sturlsa on lha haalBi assets ol DOT. 000 and DOE dpNW iRpVM wnfwmWL ffr oubk mmunooooiy. rdsOQiMM and davatopmantal toakRy). Exposure lavals In humans Mng near hazardous waste dtae and oBtar poptMtana, such as ex posed worfcem.
Potardd candUMa for aubragialry d>
State Univordtyot Now York at BuSda State UnNarsOy ol Now York at Oswego.
MOspn 9VI \X9mWKf. University ol nod at Chicago. nlH--Q-----M-----M-l ^MpInMraOl VHOT mBhWS 9ft0iwCiMal OeMiMa State Univarsky ol New York at BuNdo. State University ol New York at Oweego. MkNgan State UnNarsky.
Unheraky at Mnoie at Chicago. Wisconsin Department otHaafthand SocMServtoas.
irrWx--O----O-----f-lln- eMw -p___H-xV--M-- --falgOjl lMlA^mdtAivSMnt AMgkOgdBal fiifiiMa
(PR Doc aa-asaa nisd B-d-aa; arB ami
BFG40717
BFG . 00212