Document rxRYgKQpNyavNZ7R63r0vgo9e

TO: Dave Penney-Austin --..(L!jw Interoffice Communication FROM: DATE: SUBJ: T. G. Grumbles November 13, 1991 ATSDR PRIORITY DATA NEEDS Attached is the ATSDR federal register announcement on their initial priority data needs analysis for 38 chemicals. Benzene and vinyl, among others, are included. Joe has requested that the VI get involved with vinyl. I haven't heard of any group dealing with benzene but CMA does have a benzene panel. \l cJv----------- T. G. Grumbles dlj Attachment Wtf 000003115 52178 Federal Register / VoL 50, No. 201 / Thursday. October 17,1991 / Notice* DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency lor Toxic Substances and Disease Registry fATSDR-42] Identification of Priority Data Needs for 36 Priority Hazardous Substances AGENCY: Agency for Toxic Substances and Disease Registry (ATSDR). Public Health Service (PHSJ, Department of Health and Human Services (HHS). ACTION: Request for public comments on the Identification of priority data needs for 36 priority hazardous substances. summary: This notice announces the initiation of the ATSDR SubstanceSpecific Applied Research Program as mandated by the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) by announcing for public comment the priority data needs for 38 hazardous substances. The exposure and toxicity priority data needs contained in this notice have been identified from information gaps via a Decision Guide that was published in the Federal Register at 54 FR 37618, September 11,1988. The priority data needs represent essential Information required by ATSDR and State agencies to perform public health assessments of persons at risk of exposure to substances released from hazardous waste sites. Research to All these data needs will contribute to determining the types and/or levels of exposure that . may present significant risks of advene health effects in humans exposed to the subject substances. The priority data needs identified in this notice reflect the opinion of the Agency, in consultation with other federal programs, of the research necessary for fulfilling its statutory mandate under CQICLA and are not intended to represent the priority data needs for any other program. Consistent with section l04(i)(12) of CERCLA. as amended (42 U.S.C. 9612) nothing in this research program shall be construed to delay or otherwise affect or impair the authority of the President the Administrator of ATSDR, or the Administrator of EPA to exercise any authority of the President the Administrator of ATSDR, or the Administrator of EPA under any other provision of law, including TSCA and FIFRA, or the response and abatement authorities of CERCLA. In initiating this research program, the Agency has worked with other federal programs to determine common substance-specific data needs, and mechanisms to implement research, i.e^ via the Toxic Substances Control Act (TSCA), the Federal Insecticide,____ ADDRESSES: Comments on this notice Fungicide, and Rodenticide Act (FIFRA), should bear the docket control number private sector voluntarism, or through ATSDR-42 and should be submitted to the direct use of CERCLA funds. - Government funded projects that the Division of Toxicology, Agency for Toxic Substances and Disease Registry, involve the collection of information from 10 or more respondents will be subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act Overall, data generated from this research program will lend support to other* involved Inhuman risk assessment*; involving these 38 substance&by -Tr7. reducing inherent scientific uncertainties. The 38 substances, which were selected from ATSDR's List of Priority Hazardous Substances (52 FR 12866, April 17,1987), are aldrin/dieldrin, Mailstop E-29,1600 Clifton Road NR, Atlanta, Georgia 30333. Requests for Priority Data Needs documents, or the ATSDR Cross-Substance Priorities document, should be addressed similarly. Comments on this notice will be ivailable for public inspection at the Agency for Toxic Substances and Disease Registry, Building 33, Executive Park Drive, Atlanta, Georgia (not a mailing address), from 8 a.m. until 4:30 pjn., Monday through Friday, except for legal holidays. arsenic, benzene, beryllium, cadmium, FOR FURTHER INFORMATION CONTACT: carbon tetrachloride, chloroethane, The Division of Toxicology, Agency for chloroform, chromium, cyanide, p,p'- Toxic Substances and Disease Registry, DDT.DDE.DDD, di(Z> Mailstop E-29.1600 Clifton Road NE* ethylhexyl)phthalate. lead, mercury, Atlanta. Georgia 30333. Telephone: 404- methylene chloride, nickel, . - 639-6001. polychlorinated biphenyl compounds, polycyclic aromatic hydrocarbons - SUPPLEMENTARY INFORMATION: (includes 15 substances), selenium, - - Background tetrachloroethylene, toluene, ... trichloroethylene, vinyl chloride, and zinc.- -- "i-'f-i The priority data needs for these 38 "' substances are presented below. The Comprehensive Environmental Resfonse, Compensation, and Liability Act (CERCLA) (42 U.S.C. 9604 (i)), as amended by the Superfund Amendments Comments from the public are invited and Reauthorization Act (SARA) (Pub. on individual data needs. After L. 09-499), requires that ATSDR: (1) consideration of comments received, the Develop jointly with EPA a list of Anal priority data needs for eaclt^*. y:y* hazardous substances found at National substance will be published and a Priorities List (NPL) sites (In order of . research program will be initiated to ftBv -priority). (2) prepare Toxicological the data needs. Profiles of these substances, and (3) - Private sector organizations, that assure the initiation of a research - agree with the priority of the data need, program to All identified priority data may volunteer to conduct research to All needs associated with the substances. sporific priority* data needs IdentiAed In This ATSDR Substance-Specific this notice by Indicating their interest Applied Research Program is directed to during this public comment period* A - supply additional Information necessary CERCLA Subatance-SpedAc Applied -{Le- priority data needs) for ATSDR to Research Program Committee comprised perform comprehensive public health^ of scientistsfrom ATSDR. the National assessments for populations living in the Toxicology Program (NTP), and the vicinity of hazardous waste sites. This Environmental Protection Agency (EPA) link between research and public health will review all voluntary research' assessments, and the process for efforts proposed. . ?: ~ jlistilling priority data needs for ranked t The substance-speciAc priority data, - hazardous substances from informatioi ~ needs were based on and determined * gaps found in associated ATSDR from information in corresponding .Toxicological Profiles, la described in' ATSDR Toxicological Profiles; ' ,, the ATSDR Decision Guide for Background technical information and Identifying Substance-Specific Data justiAcation for the priority data needs Needs Related to Toxicological Profiles- identified in this notice is contained In - (54 FR 37618, September 11,1989). fl Priority Data Needs documents and the " relationship between information ga ATSDR Cross-Substance Priorities _ and priority data needs is shown in., document. These documents araH' FigureJ.,) Briefly, this guide identified available for review by writing to the-,t categories of exposure and toxicity * ATSDR at the address listed in the - needs necessary to assess the four I AdorE**cs section of this notice, il 1-, steps involved in performing public DATES: Comments concerning this notice health assessments. must be received by January 15,1992, osU& OOQO Federal Register / Vot SO. No. 201 / Thursday, October 17, 1991 / Notices 52179 Exposure Assessment--(l) Environmental Pathways, (2] Human Contact Hazard Identification--(3) ~ Toxicokinetics, (4) Physiologic/Health Effect The linkages between the release of a hazardous substance in the environment and impact on human health can only be fully determined when the scientific underpinnings for these four basic steps are available, in the absence of these data, the public health assessment process necessarily Involves using certain assumptions. Filling the data needs related to these four steps will lead to reduced uncertainty in such assumptions. The relationships between these four steps and priority data needs are as follows: Exposure Assessment Of importance to ATSDR in meeting its statutory mandates is the need to make reasonable scientific assessments based on levels of contaminants found in the environment at or around CERCLA sites. In order to accomplish this goat a major objective of this research program is to establish linkages between levels of contaminants in the environment and levels in tissue/ target organs that are associated with an adverse health effect ATSDR' understands this requires (1) the development and validation of sensitive analytical methods for measuring levels of contaminants in environmental ntediia; (2) information on background levels in die general environment (3) information on contaminant levels at or near hazardous waste sites: and (4) knowledge of contaminants' ~ environmental fate. Further, extending environmental contaminant levels to human tissues concentrations requires (1) the development and validation of sensitive analytical methods for contaminant detection inhuman tissues; (2) bioavailability data; (3) Information on background levels in non-exposed populations: and (4] information on levels in tissues for populations living at or near hazardous waste sites. Thus, a major priority data need for this data needs research program will be to collect (where appropriate), evaluate, and interpret data for both environmental media and human tissues for environments and populations around hazardous waste sites. Hazard Identification Toxicology and pharmacokinetic testing of priority hazardous substances is vital in order to identify target organs and to establish tissue dosimetry. This information is critical in completing the association among levels of these substances in the environment, levels in established under section 4(e) of the human tissues, and levels associated Toxic Substances Control Act on the with adverse health effects. When types of research to be done. ATSDR Is information is lacking to identify the an active participant in this committee; most sensitive target organs (and doses none of the proposed 33 substances are associated with these effects) following being considered by the ITC at this time. acute, intermediate and chronic exposures to each substance, it A TSCA/FIFRA generally will .become a priority data need; and the identified health effect studies will be conducted via the most relevant exposure route(s) representative of conditions at hazardous waste sites. Currently, ATSDR does not extrapolate toxicity data across exposure routes or exposure durations. However. ATSDR acknowledges that such extrapolations may be done on a substance-by substance basis after toxicokinetics information has been established. Once linkages have been established across exposure routes, between levels in the environment, and levels in specific human tissues associated with health effects. It should be feasible to develop strategies for mitigation of these effects. Mechanistic studies can be In the development and implementation of the research program, ATSDR and EPA have established ' 7 ': procedures to identify priority data~"`?f^ needs of mutual interest to federal ` 1 programs. Generally, this begins during, or prior to, the finalization of the priority data needs. These data needs will be - filled through a program of toxicological testing under TSCA or FIFRA. This portion of the research will be conducted according to established TSCA/FIFRA procedures and guidelines. This testing will fulfill more than one federal program's need. It is ATSDR's intent to ensure that data needs pursued under TSCA/FIFRA ... administrative arrangements are subject to independent scientific peer review. undertaken to elucidate the A Private Sector Voluntarism - ,-j pathophysiology of the health effects; leading ultimately to the development of clinical methods for mitigating any adverse health effects of exposure to persons living around hazardous waste sites. The final point to be noted in the The ATSDR encourages private sector voluntary conduct of research on select priority data needs. Private sector organizations, that agree with the . _ priority ofthe data need, may volunteer to conduct research to fill specific development of this applied research priority data needs identified in this program is the heavy reliance on the collection of quality human data to notice by indicating their interest: during this public comment period. Concept validate the substance-specific exposure .proposals (1-2 pages), not detailed study and toxicity findings evidenced from animal studies and equivocal human designs or protocols are solicited at this time. A review committee comprised of studies. This information will be scientists from ATSDR, the National obtained by conducting exposure and Toxicology Program (NTP), and the.. health effects studies, and through the Environmental Protection Agency (EPA) establishment of subregistries within the - will review the voluntary efforts framework of ATSDR's National proposed. Based on the review Exposure Registry, committee's recommendations, ATSDR -Will determine which, and how, specific Implementation qfjytaics>S]Mdfic voluntary research projects will be Research Program pursued with volunteering organizations CERCLA, as amended as section (Figure 2). It is the intent of ATSDR to l04(i)(5)(D). states that it is the sense of only enter into voluntary research... Congress that the costs for conducting projects in ways that lead to high , v -j. this research program be borne by the quality scientific work. This would ' 1 ' manufacturers and processors of the include the necessity of peer review of hazardous substances under TSCA/ study protocols and results. . FIFRA, or by cost recovery from responsible parties under CERCLA. C. CERCLA ATSDR interprets the Congressional Those priority data needs that are not intent to mean that portions of this filled by TSCA/FIFRA or initial CERCLA Substance-Specific Applied voluntarism will be considered for Research Program will be conducted via funding by ATSDR through it* CERCLA regulatory mechanisms, private sector budget A large portion of this research voluntarism, and through the direct use program is envisioned to be unique to of CERCLA funds. Moreover, CERCLA, CERCLA, eg., on substances not as amended, requires that ATSDR regulated by other programs oron consider recommendations of the research needs.specific to public health Interagency Testing Committee (ITC) assessments. Mechanisms to fill these VVV 000008117 52180 Fidgfl Regiater / VoL Bfl> No. 201 -/ Thursday, October 17, 1981 / Notices priority data needs may include a second call for voluntarism. Again, scientific peer review of study protocols and results would occur for ail research conducted under this auspice. Substance-Specific Priority Data Needs The priority data needs identified in Table 1 are considered available for conduct at the discretion of ATSDR and/or EPA via mechanisms that include TSCA/FIFRA, private sector voluntarism or CERCLA. These exposure and toxicity priority data needs are divided into Groups A and B for further refinement. Group A priority data needs are the highest ranked priority data needs while Group B are priority data needs that will be filled ~ pending the results of Group A testing or that are not of the most urgent public health concern to ATSDR at the present time. No hierarchies are set among any one substance's Group A or Group B priority data needs. Reassignments between priority data need groups will be considered by ATSDR on a substance-by-substance basis pending the collection and evaluation of additional data. Additional information on Group A and B data needs can be obtained in the ATSDR document Cross-Substance Priorities. This document is available for review by writing to ATSDR at the address listed in the aooresses section of this notice. Table 1 .--Substance-Specific Priority Data Needs Grow A Group B AtdrirvOieMrire Epidemiological studies on the health effects of atom and dtoldrto (Special emphasis emJpoaXa toduda: cancer, tmmunofoncity, neurototodty, and reproductive and development# toxicity). Dose response data in anem# tor totannodiaia duration oral exposure. Arsenic Comparative tmocokinelic stodtoa to detonrine d an appropriate animal species can be MamWad Benzene: Epidemiologic# stodtoa on tie health effects of benzene (Special emphasis endpoints Muds: twasiWIiMp. aid reproducers and dovetopmont# toxicity). Doaa rasponee data In anlmalB tor acuta and Intarmedtote duration or# exposure. The aubchronto study should Muds an extended reproductive organ N#op#hotogy. a spades tiavdopmwti#tadcSy#udyvtoor#e#>oeurs.- Maisotoaicologyba#aqf#toalaviser#d#oaure. BeryfKum: Ooa* response data In Idas# tor scute- and totermadtole duration tohstolen expoaues. The aubdvonio stodf should Muds extended rsproductiwe organ hMopatitotogyi 2-epedeeOavatafnar# totoctijr study1via fnhalaSon expoews. CsdraiuaK , - -.v.. EpidsnSologic# ttodiaa on Its he#tit affects of cadmium (Spec# amphss# andpotota toduda: cancer. tan# toxicity, hapatoto#dty tmounototocRy, - nearotoataS* roaptiatoty isdclty, raproductiw and'dawatoperant# toddy, sod doaetoonaed#Bte Isas dan Mime wpoeure).. Carbon TebacMertdK Epidanioiogic# etude* on tie health effect* or CO. (Sped# snyhsU vnQpOHV slGMOK 'wVIOVi fntHUROUBGnyt fsBUimOJOCHjr* InQ rapTOOUCVW and davetoptnantoi tsHft Doae-raaponaa data to antowto tor chronic or# expoem. The study should toduda axtsmisd raproduoSve <xgan and nanroua tissue (and demeanor) histopelholo0. Chloroaihanae Epidw#oto#c# dudes on toe healthenacts of ditoroetftene (Sped# am- photos -.endpoMa- toduda. bsmunotoxictiy, neurotoxicity, end reproductive to***. -- Doaa ra^ores -data to antoiato for -acute end totarmadtoto-duraSoh or# apcaws The eubchwnto study should toctode an-evafuatton of toneme and nervous. system -far# betwvior. demeanor) tissues. and extended raproducMue organ htotopethotogy. Cmiipwtittve toiifcidrtoaSr toudaa (across routo/spedae). Chtorofonac non 01 nt nMrai vnics ov cwoionv ispiGW mpnr sia endpotota indude: cancer^ Imreunotoidcity. naurotoxtofey, and reproduo- wa ana oavetoproeniw ntocsyi Doae-raaponaa data to animais tor totarmadat-d#ation or# eiwoaweL - Chromuit Doaa ramorae data to antowfa far acuta duration exposure to chromium (VI) and (Mi) via or# nposuro and tor intermediate duration closure to - chrornfcaofVI) vto-or#e>qoaur*. Muhiganerdton mprodurMva SordoSy study #a oml-exposure to chromium (HQ and (VIL - ' UyanidK cpiOPiKNopm nxni on no nm ovvocn ov cyinos tspvcMv otrynom endpotota toduda: adverae effects on the thyroid gland, and reproductive anddmatopmant# toticJty). BioavaiibMty torn aoiL HattSvaa to sartace water, groundwater. Btoavasabitty from sod. None. Environment# tats In ati. Factors sheeting btommiaWWy to at. tovnunotoxtooioey battery of testa taSowfng or# expoam Horn. - towtunotadcotogy battery of tests via or# exposure. HdMtetoeol Doaeeaaponaa da# to animatofor chronic inhaiaBon toqnaurea. The pudy ~ toduda an evtouation ot-nerroua system (# bshevtor) leauaa. ..... None. tomtvag.utuiucoiegy battery of tests following or# exposure to chromtom (HQ , ,Sdpectas devotopmontol toxicity study or# exposure to chromtumimy ^ :.% Evstorton of the enwronmentai fate ot cyanide to aoi. Vi Kf&t-* vvv 00000811 Federal Register / Vol 50, No. 201 / Thursday. October 17, 1991 / Notice* 52181 Table i.--Substance-Specific Priority Data Neeos--Continued Group A Groups Oose response data in emmds lor acuta- tod Htermecbete-duratxin expo sures da inhalation. The subchronic study should include extended rapro- ductiv* organ htop*Oology and evHuabon or neurobeftavioral and neuropathological endpoint*. 2-Specie* devewpmontd towcrty study via oral exposure. pp'-OOT, DDD, DOE; Epidemrotogicd Hutto* on ft* Maim effect* of DOT, OOD and DOE {Special Bioavaiiabiiity and Woeccumulabon from sol. emphasis endpoints include: cancer, Immunotowaty, neurotoxicity, and reproductive and developmental toxtatyV Boss response data in animals lor ctwonjoduraiion oral expoeure. Comparative toMookineae study (across routee/spedee). :; .x DHS-ethytoexyOphthaiate: Epldemtotoglcd Huttos on the health effects ot DEHP (Special emphasis Nona. endpoints include: cancer and reproductive and davatopmentd toxicity). Ooaa response data in animals tor acute- and HtetmedUiie-duration oral exposures. The subchronic study should include an extended histopathoto- gicai evaluation of the immunologic and neurologic systems. MuMganaration reproductive toxicity study via oral exposure. Comparative tojpcoionetic studies (Studies designed to examine how mam mals metabolize and distribute DEHP as compared to rodents via oral exposure). Lead: Epidemiological stutoe on the health effects of lead (Special emphasis None. endpoints Include: cancer, hematopoietic toxicity, neurotoxicity, ImmunotoxL city, reproductive end developmental toxicity, and dose response data). Mechanistic studies on the neurotoxic effects of lead. Mercury: Epidemiological studfee on the health effects of mercury (Special emphasis endpoints include: cancer, immunotoxicity, neurotndctty, and reproductive and developmental toxicity). MuMgeneraton reproductive toDddty study via oral expoeira. Immunotaxleotogy battery of teats vte ord exposure. Cardnogenidty testing (2 year btoaasay) da ord exposw - .L* f j aisL. live 5 z *,> Methylene Chtortde: Doeslesponaa date.kt.anknMe lor acute- end Wsrmedtots-duratton-crd None. **>' exposure. The subchronic study should Include extended raproducthw organ Nstopethotogy, neuropathology and dsmaanor, and Immunopelho* oar- 2-spades derotopmentd todofcy study via the oral route. Mdwfe . ,------ - - J J\ ' .yrro?* Epidemiological stuctoe on Ota health effects of nfcfcel (Spadd emphasis endpoint* Indude: cenoer, immunotoxicity, neurotoddty, and reproductive n onuRpTwnn ummu^ Poes respones data to snimats -for touts and Interroettote-duratlon oral Neuotoxtootogy battery of test* da ord ettooeura. BtoavdtobMy of nlcfcd Irom sol. . 'i ' . ~ , 'Tt.YSfr* ,:--7*vrnK toosuree.-- ' rsi^r-...... pofycraommo npMfijfi compounoK Epldemtotoglcd stadias on the hialto effects of PCS* (Special emphasis endpoints Indude: cancer, knmunotnddty, gaitroNestlnd toxicity, thyroid toaddty, hsmatopoiette toricdy, and reproductive and developmental tcadd- tyL Fhotodegradatton of PC8a In to and water. BtoavWtobStty ot PC8* in to. aratsr and so*. Does respones data In animal* for acuta- and Intermadtotedurattan Wtdatton etooeuree. The eubchronto saidy should Include extended reproductive Nstopathotogy. Dose rosponee data In ankrato for acute- tod irtermedtste-duratton oral Pofycycfcc Aromatic Hydrocarbons (include* 18 substances); stuctos on the hetoh effects of PAHs (Sped* emphasis Does response data In animdr for acute and NermedtoteduraMoninhalation endpoints indudac cancer, knmunetoxtchy, raproducthre and dsvstopmsntal amoeutea. The eubohrorle study should include extended reproductive organ tcsbdty, and advene aldn effects). **" ^histopdhology and Nmunopathoiogy. Ooaa-reaponaa |*** in animals for totsmadhita duration oral exposures, The Machailsio eludes on nondtemant PAHs, on how mixhfea of PAHs can subchronic study should indude extended reproductive organ hlitcpalho- inference the ultimate activation of PAHs, and on how PAHs affect rapidly logy and immunopashology. proHeraUng tissues. 2-Sptdss dsvstopmsntal toxicity study via Inhalailon or oral exposure Ssledunt -. - -- - - - *- * --*- - - - . . Epidemiological stoctoa on the hetoh affects of sdanium (Spadd ampheei* fnvmmotoxlcatogy battery ofliasis via ord exposure. .endpoint* Indudac cancer, Immunotoxicity, raproductoa and dwratopmentd roncny, mpmuHLiy ino mwiv won mciih -'nSf* Oote-reaponee data in animals for acute-duration oral sipMura, * TtotoMutuotoylanas ' Epidemidoglcd rturtos on too health effects of Istrachloroethytans (Spadd emphasis endpoint* Include: cartoer. knmunotatodty, reproductive and de- rWQpnlWi wfOCdyi fWpWRKRf Vm nVUlQVQDGtofp Dose response dale In atonda for acute-duration oral exposure, Inducing Dose response data In animals for chromo-duration ord exposure. Including' neuropethotogy and demeanor, and Inwnunopathotogy. 2-Speda* developmental toxicity study da ord exposure. nauropsrthotogy end demeanor, and townunopathotogy. MuMgenereSon reproductive toxicity study via oral exposure. '*T Toluene: Doee rosponee data in animal* for acuta- and Intsmteditteduratton oral Mechanism of totosne Induced neurotoxictty. sxposuraa. The subchronic study should Include an extended histopathoioi- cd evaluation ot the immune eystem. Comparative totoookineac studies (Charactertzailon of absorptkxt. dtobtwtlen, and excradon ds ord exposure). Neurotoxlcotogy battery of tests da oral exposure. vvv 000008119 52182 Federal Register / Vol. 56, No. 201 / Thursday, October 17, 1991 f Notices Table 1.--Substance-Specific Priority Oata Needs--Continued Qraw A Gmp e Trichtoroethytona: Epidemiological xtudies on the health effects of trichloroethylene (Speoal emphasis endpoints mtiude: cancer, developmental toxicity, and neurotoxi city), Does response data In animals for acute-duration oral exposure. Vinyl Chloride: Epidemiotogicai etudes on the health effects of vinyl chloride (Spatial empties* endpoints include: cancer, immunotoxicity. reproductive and daremprnanm tono*, hepatotoxitity, and neurotoxicrty). Doee-teaponae data Si animali tor acute-duration inhalation exposure. Multigeneration reproductive tontity study via inhalation. Ztoe Ooaa raaponaa data in animals tor acut* and intermediate-duration om eimosuras. The aubchronc study should include an extended hrslopethotoical evaluation of the immunologic and naurological systems. Muttigeneratton ieproducdve toxicity study via oral exposure. Cartinogonicity testing (2-year bioassay) via oral exposure. Neurotoxicology Pottery of tests via the oral route, tmmunoioxicotogy battery of tests via the orat route. Dose raaponee data In animala tor chronto^uration inhalaMon axpoaure. Mitigation of Wiyl chtorida Induced totochy. 2-species developmental toxxaty study via inhalation. Nona. As previously stated ATSDR considers that a portion of this research will be most appropriately conducted utilizing CERCLA data and resources. Toward this end. ATSDR has identified particular data needs that will be considered for implementation by ATSDR programs. These priority data needs fall Into both the exposure and toxidty data needs categories. A mafor exposure priority data need for this applied research program will be to collect evaluate, and interpret data from contaminated media around hazardous waste sites: and this has been identified by ATSDR as a priority data need for all 38 substances. However, ATSDR realizes that a large amount ofInformation has already been collected through individual state programs and the EPA's CERCLA activities. ATSDR will therefore evaluate the extant information from these programs in order to help fill data needs on substance-specific exposures. ATSDR's role as a public health agency addressing environmental health it, where appropriate, to collect human data to validate substance-specific exposure and toxicity findings. This information will be obtained by ATSDR through the conduct of exposure and health effects studies, and through the establishment and use of substancespecific subregistries of persons potentially exposed to these substances within the Agency's National Exposure Registry. When a subregistry, or a human exposure study is identified priority data need, the responsible ATSDR program will consider this recommendation and determine its feasibility, dependent on identifying appropriate populations and funding (Table 2). These priority data needs may be reclassified following considerations of feasibility, and any reclassification will be published in the Federal Register. . ATSDR acknowledges that the conduct of human studies to determine possible linkages between exposure to hazardous substancesand human health effects may be accomplished other than by Agency programs or under other ATSDR-sponaorad auspices. Toward *" that end, the private sector and other governmental programs are encouraged to use ATSDR's priority data needs to plan their research activities, La, to-.nii. Identify appropriate populations arid ^ conduct studies answering die specific' * human health questions. Table 2.--Substance-Specific Priority Data Needs for Consideration by ATSDR Programs Subattncs Priority Human Data Needs AUrin/Dieidrift. Annie. Benzene. BeryHum. Cednaum. Cartoon TetoecMoride. CMoroefhene. Chtoroform--. Chromium. Cyanide. P-P'-GCT, DOO, DOE. Emoeura levele to humane Bring near hazardous warns eSee and other popdatoons, such as wortoars --pwtri to tidrin and dieldrin. ...... Candklats tar aubrsgislry ot exposed parsons. Exposure levels in humane totog near hazardous waste sites and other populations, such as work** riposml to Exposure levels to humane Bring near hazardous waste sitea end other populations, such as workers sipotid to Exposure levels to humane Bring near hazardous waste sites and other populations, such as workers minisit to-' bsryhum ~ - - -- j Exposure toveie to humane Bring near hezardoue waste sees end other populations, such as werkms exposed* cadmium. _ Evaluation of existing regietoot of expossd persona. . . . Exposure levels to Humana BrinQnear hazardous waste sites and other populations, such as workers exposed to CClbl CsindWale tor sttoregMy of exposed persona. Cendtoate tor aubragistoy of axpoaed persona. Exposure tovets to humane Ivtog near hazardous waste sites end other populations. such as workers aapoead ke CrKOfOMVft Candfcisl* for subregistry of exposed persons. Exposure levels to humans Bring near hazardous wests site* end other populations, such ee worker* chromium. Candxtote tor eutoregistiy of exposed person*. _ Exposure levels to humane Bring near hazardous waste sites and other populations, such ee workers mqioaed cyanide. Candidate lor eubregisfey of exposed peraona. Exposure level* to humane Bring near hazardous waste etoee end other populations, such as workers eimcesd DOD. and DOE. CandUate tor subregistry of exposed persona. VVV 000008120 Federal Begietaf / VoU No* 201 t Thursday, October 17* 1901 / Notices 52109 Table 2.--Substance-Specific Priority Data Needs for Consideration by ATSDR Programs--Continued Substance DateNeeds Di(2-ethylhexyi)phthalate............-...... ..............- Exposure leva* in humane hmg near hazardous watte near utf oBtar pnpililnin such as workers exposed to DEHP- Candidate tor subregistry of exposed persons. Exposiae leeea in bumaas ttnrn near naaartauawBf sfta* sett oma fUiaWtens.aichtt workers exposed to lead. Candidate tor sutragfeiry of exposed penon*. Exposure levels in humans vmg near hazardous waste sdn and other populations, such as worker* exposed to Methylene Chloride. Nickel. Polychlorinated Biphenyl Compounds..... Polycyclic Aromatic Hydrocarbon* (includes 1$ substances). Selenium.-.... ........... ......................... ................. Tehechloroethyiene------ -------------- Toluene. Trichloroethylene-- Vmvl CNoride. 71"e --.... . V. Candidste lor subregistry of exposed persons. Exposure levels in humane bring near hazardous waste sites and other populations, sueft as workers enosed to methylene chloride. Candtoste for subregistry of exposed persons * t Exposure levels in humans living near hazardous waste sites end other populations, sueft as worksrs to racket. Candidate lor subregtsby of exposed persons. E&osure levels In humans living near hazardous waste sites and other populations, sueft as workers apposed to PC8*. Candidate for subregistry of exposed persons. Exposure levels in humans living near hazardous waste sites and other populations, sutin as workers exposed to PAH*. Candidate for subregistry of exposed persons. Exposure levels m humans Hvwg near humous waste sites aad ether populations, such as utters exposed to selenium. Candidate for subregistry of exposed person#. Exposure levels in humane living neaa heattdaee waste sites and other populations, such as -workers exposed to tetrachftwoethyiene. :^ Candidate lorsubregotry of expoeedpersonae. ~ '' Exposure levels, m humans living near hazardous watte sites end othes papuMbm. such as worker* exposed to toluene.. TV Candidate for aubrei^tey of--posed persons. -- Exposure levels to humww hto^oear hazardous waste wtet ed otter pepteattmt. such as workers exposed to trichforosthyleaai T .,, toExposure levels turaewe Mnq wear hteerdoua weete dtes amt ether $ Bpehlef, such as worker* exposed to vinyl chloride. - - - V". - ' - - * j Candidateforiidiiagttyetsugamfuwsaite Ettooeure levels to NrtteneSdhg near fteawdou* wane aae* matotter pepatotete. such as workers exposed to ztrac. Candidate lor stAtegiMytttepoeedeera^te 't Dated: October 9,1901. Walter ILDowdla, ActingAdministrator. Agencyfor Toxic Substances andDisease Registry. BtLUNQ COM 41SS TO M i. -V-^ r.J\. ^;; ;T:yi * Si.-*J.-'t.> t* -- ' t ' - ^ *y-'- ->R -4 * 4 . a1 ^ T- ;Jt ' " T-j,- '"ws wv 000008121 - 52184 Federal Register / Vo!. 56, No. 201 / Thursday. October 17,1991 / Notices Figure 1. Distillation of ATSDR's Priority Data Needs Information Gaps Groups__ _ A, B, C Decision Guide Data Categories s...! 1 ;' ,04 *~.n: J* wvl -.flt Groups A, B Decision Guide SubstanceSpecific Priorities Group A Group B vVV OOOOOS122 Federal Register / Vo!. 56, No. 2D1 / Thursday, October 17,1091 / Notices Figure 2. ATSDR's Initiation of its Superfund Applied Research Program to Fill Priority Data Needs ATSDR PubBshea Initial Set of Priority Data Needs 62185