Document nmaNX4KVMrgkgRjJkYz6RvGEa

11434 Federal Register / Vol. 59, No. 47 / Thursday. March to, 1994 / Notices DEPARTMENT OF HEALTH AND at any time to conduct research to fill of science, including risk assessment of HUMAN SERVICES identified data needs, until ATSDR chemicals, thus creating a scientific base Agency for Toxic Substances and announces that research has been initiated for a specific data need. for filling a broader range of data needs. CERCLA, in section 104(i)(5)(D). V Disease Registry ADDRESSES: Private sector organizations states that it is the sense of Congress [ATSDR-79] interested in volunteering to conduct* this type of research maywrite to Dr. that the costs for conducting this research program be borne by the Status of the Superfund Substance* William Cibulas, Chief, Research manufacturers and processors of the Specific Applied Research Program Implementation Branch, Division of hazardous substances under the Toxic AGENCY: Agency far Toxic Substances and Disease Registry (ATSDR), Public Health Service (PHS), Department of Health and Human Services (HHS). ACTION: Notice. SUMMARY: This notice provides the status of ATSDR's effort to Implement the Agency's Substance-Specific Applied Research Program (SSARP). This research program, authorized by the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), as amended by the Superfund Amendments and Toxicology, Agency far ToxicSubstances and-Disesse Registry, Mailstop E-29,1600 Clifton Road, NR. Atlanta, Georgia 30333. FOR FURTHER INFORMATION CONTACT: Dr. William Cibulas. Chief. Reseerch Implementation Branch, Division of Toxicology, Agency for Toxic . Substances and Disease Registry, Mailstop E-29,1600 Clifton Road, NR. Atlanta. Georgia 30333. telephone (404} 639-6306. SUPPLEMENTARY INFORMATION: Background Substances Control Act (TSCA) and by registrants under the Federal Insecticide, Fungicide, and Rodentiddo Act (FlFRA). or by cost recovery from responsible parties under CERCLA. To effect this statutory intent, ATSDR developed a plan whereby parts of the SSARP will be conducted vie regulatory mechanisms (TSCA/FIFRA), private sector voluntarism, and the direct use of CERCLA funds. A Tri-Agency Superfimd Applied Research.Committee (TASARC) comprised of scientists from ATSDR. NTP. and the EPA has been set up to: (1) Advise on the assignment of Reauthorizedon Act (SARA) [42 U.S.C. 9604 (i)l. was initiated on October 17, 1991. At that time, a list ofpriority data The Comprehensive Environmental. Response, Compensation, and Liability Act of 1980 (Superfimd) or CERCLA, aa priorities on mechanisms for filling data needs: (2) coordinate knowledge of research activities to avoid duplication needs for 38 priority hazardous amended by the Superfund of research in other programs and under substances was announced in the Amendments and Reautborization Act ofoer.aufoorities; (3) advise on issues f Federal Register (56 FR 52178). Hie list (SARA) [42 U.S.C. 9604(1)), requires that sdence related to substance-specific was subsequently revised based on public comments, and published in ATSDR (1) Jointly with the Environmental PiotectionAgancy data needs: and (4) maintain a scheduled forum that provides an final farm on November 16,1992 (57 FR (EPA), develop and prioritize a list of overall review of the ATSDR SSARP. 54150). hazardous substances found at National The TASARC has met four times since Hie 38 substances, each of which is found on ATSDR's "ListofPriority Hazardous Substances'" (56 FR 52166. October 17,1991), are aldrin/dieldrfn, arsenic, benzene, beryllium, cadmium, . Priorities List (NFL) sites, (2) prepare toxicological profiles for these substances, and (3) assure the initiation of a research program to fill identified . date needs associated with the foe initiation of foe SSARP. This notice Strides the status of ATSDR's efforts to pfesnent the SSARP, focussing on ongoing activities relevant to test rule development under TSCA/FIFRA, carbon tetrachloride,ddaroethans, substances. Before starting such a private sector voluntarism, and direct chloroform, chromium, cyanide, p,p'- program, ATSDR will consider use of CERCLA funds. Additional data DDTJ3DEJ3DD, di(2- recommendations of the interagency - needs are being addressed through an ethylhexyl)phthalate, lead, mercury, Testing Committee established under - interagency agreement with NTP, by methylene chloride, nickel, section 4(e) of die Toxic Substances ATSDR's Great Lakes human health polychlorinated biphenylcompounds Control Act on the type of research that effects research program, and other (PCBs), polycyclic aromatic should be done. Agency programs. To date, 59 priority hydrocarbons (PAHs) (includes 15 . On October 17,1991, ATSDR . data needs associated with 35 ATSDR substances), selenium, tetrachloroethylene, toluene, trichloroethylene, vtnylchkrride, and announced the identification of the priority data.nee<fe for 38 priority - hazardous substances (56 FR 52178), firiority hazardous substances including 15 PAHs) are being addressed via these mechanisms (Table zinc. --- ; This notice also serves as a continuous call for voluntary research requested publiccomments, and invited 1). . private sector organizations tovolunteer to conduct research to fill specific A. TSCA/FIFRA initiatives. ATSDR encourages private priority data needs. On NovembvML, ' In developing and implementing the sector organizations to volunteer to 1992. the Agency published a revised SSARP, ATSDR, NTP, and EPA have conduct research to fill specific priority list of 117 priority data needs for these established procedures to identify data needs. A Tri-Agency Superfimd priority hazardous substances (57 FR priority data needs ofmutual interest to Applied Research Committee (TASARC) 54150). Federal programs. These data needs will comprised of scientists from ATSDR, . The major goal* of the ATSDR SSARP be filled through a program of the National Toxicology Program (NTP), are: (1) To fill the substance-specific toxicological testing under TSCA. This and the Enviirrcrniental Protect!on information needs of the public and portion of foe research will be Agency (EPA) will review all proposed scientific community, and-(2}to supply conducted according to established voluntary research efforts. information necessary to conduct TSCA procedures and guidelines. This OATES: ATSDR considers the voluntary comprehensive publichealth - testing will fulfill more than one Federal research effort to be important to the assessments of populations living near program's need. During FY1993, a continuing development of the SSARP. hazardous waste tiles. This program subset of the 117 priority data needs for Therefore, the Agency encourages also will provide data that can be 38 substances (about 60) was referred to private sector organizations tovolunteer generalized to other substances or areas foe EPA under its authorities following R&S 144846 Federal Register / Vol. 59, No. 47 / Thursday, March 10, 1994 / N tices 11435 review and endorsement by the Currently, ATSDR is pursuing minority citizens. The purposes of the TASARC oversight committee. voluntary research interests with two ATSDR-MHPF cooperative agreement Currently, 26 priority data needs private sector organizations: the General are: (1) To initiate research to fill associated with 11ATSDR substances Electric Company (GE) and the ATSDR-identified data needs for have been recommended by EPA to be Halogenated Solvents Industry Alliance priority hazardous substances, and (2) to added to its Master Testinglist, the first (HSIA). To date, through the voluntary wnimnce existing disciplinary capacities step in test rule development under research efforts of GE and HSIA, four to conduct research In environmental TSCA, section 4 (Table 2). Please note priority data needs for two substances health at MHPF member institutions. that although ATSDR has identified priority data needs for oral exposure to tetrachloroethylene, cyanide, and beryllium, in response to other Federal are under discussion, potentially leading to the of two memorandums of understanding (Table 3). The areas of research at MHPF inf+ityHnna include those related to broad areas of toxicology and environmental health science. Some of government agency needs, ATSDR will consider proposals to conduct inhalation studies in conjunction with pharmacokinetic studies for these During FY1993, ATSDR staff members met with officials from GE to discuss the Agency's research agenda for PCBs. The Agency has Identified the MHPF member institutions are ww^iwrHwg health studies of minority groups exposed to ATSDR's priority hazardous substances. i substances in lieu of bioassays using oral exposures. It is anticipated that inhalation data derived from these studies can be used, in conjunction with pharmacokinetic modeling, to address ATSDR's oral toxicity data needs. Some of ATSDR's priority hazardous substances will not be added to EPA's Master Testing list because they do not fall within the bounds of TSCA, Section 4 authority. For example, TSCA does not require testing chemicals that are out of production, such as PCBs. Furthermore, TSCA is not considered the appropriate mechanism for testing PAHs, because the PAHs are by mutual interests in environmental fate testing and human health endpoints assessments and has initiated discussion on these studies with GE. ATSDR met with HSIA representatives to discussthe use of^" noIogiCTlly-based~pfiamiacolc@iC- iPKl models to fill priority datanaeds for six volaSIe^pnicTOmpoupdg. The Agency selected methylene chloride to start using PBPKi ATSDR's toxicity priority data needs because of the extensive database on this substance. The toxicity priority data needs for the remaining 5 volatile organic compounds (carbon tetrachloride, chloroethane, chloroform, D. National Toxicology Program ATSDR maintains an interagency agreement (IAG) with NTP to conduct toxicological testing of substances identified at NPL sites. The studies determine levels of exposure that present a significant risk to humans of acute, subacute, and chronic health efforts. Often these studies include an assessment of the substance's ability to cause cancer, reproductive toxicity, and birth defects. The results of these studies are used by regulatory agencies such as the Food and Drug Administration and the EPA, various environmental and industrial groups, products of multiple industrial tetrachloroethylene, and and ATSDR to improve the ability to . processes and. therefore, it is difficult to trichloroethylene) may be addressed via conduct public health assessments at identify specific manufacturers. In rimllaf voluntary efforts in the future. NPL sites. Under this agreement, one addition, TSCA guidelines are not available for some of the ATSDR C. CERCLA-Funded Research (Minority toxicity priority data need identified in , the SSARP (carbon tetrachloride, priority data needs such as the Health Professions Foundation Research immunotaodcology battery of tests via development of analytical methods for Program) oral exposure) is currently being cadmium and beryllium, mechanistic During FY 1992, ATSDR announced a addressed. This NTP study was begun studies on the neurotoxic effects of lead, and the mitigation of toxicity of vinyl, chloride. Moreover, some ofthe ATSDR priority hazardous substances are considered more appropriate for FIFRA $4 million cooperative agreement in September 1993 and should be program with the Minority Health completed in February 1994. Professions Foundation (MHPF) to support substance-specific *5. Great Lakes Human Health Effects investigations. This cooperative venture Research Program than TSCA, e.g., arsenic, DDT, and is supported by.the direct use of Some of the priority data needs aldrin/dieldrin. The Office of Pollution, CERCLA funds. During FY 1993, about identified in the SSARP have been Prevention and Toxics (OPPT), EPA, $4 million was allocated to continue independently Identified as research forwarded the data needs for these this research program; no new projects needs through the ATSDR Great Lakes substances to the Office of Pesticide were initiated. Currently, 9 priority data human health effects research program, Programs for evaluation. needs for 21 priority hazardous a separate research program. To date, 12 B. Private Sector Voluntarism substances (including 15 PAHs) in the SSARP are being addressed by the priority data needs for 19 priority hazardous substances (including 15 - As part of the SSARP, ATSDR MHPF institutions through this PAHs) identified in the SSARP are being initially announced a set of proposed program. Also, the MHPF research . addressed through this program. The , procedures for conducting voluntary program will address 13 other institutions receiving awards and their research on February 7,1992 (56 FR substancespacific data needs identified respective studies are listed in Table 5. 47S8). It was revised based on public in the ATSDR toxicological profiles The Great Lakes Critical Programs Act comments and published on November concerning exposures and related health of 1990 mandates EPA, in cbnsultation 16,1992 (57 FR 54160). This voluntary effects. The institutions receiving with ATSDR, to prepare a report by research program fills priority data awards and their respective research September 30,1994, that assesses the needs along with other mechanisms such as test rule development through pProTjheecMtsHarPeFli,satendoitn-fTora-bplreo4fi.t 501(c)(3) adverse effects of pollutants in the Great takes system on the health of EPA and CERCLA-funded research. organization, is comprised of 11 individuals in the Great Lakes states. A Private sector organizations were minority health professions schools. Its variety of persistent toxic substances are encouraged to volunteer to conduct primary mission is to research the prevalent in the'Great Lakes, including research to fill these specific priority persistent health problems that PCBs, DDT and its metabolites, dieldrin, data needs. disproportionately plague poor and toxaphene. mirex, mercury. R&S 00 11436 Federal Register / VoL 59, No. 47 / Thursday, March 10, 1994 / Notices benzo[a]pyrene, hexachlorobenzene, furans. dioxins, and lead. Certain populations--Native Americans, sport anglers, fetuses and nursing Infants of mothers who consume contaminated Gnat Lakes fish--have a potentially higher risk of long-term adverse effects resulting from exposure to these contaminants. The ATSDR-supported research projects focus on these high-risk populations to try to further define the human health consequences of exposure to these persistently toxic substances. The research activities include, but are not limited to: (1) Characterizing exposure and determining the profiles and levels of Great Lakes contaminants in biological tissues and fluids in high- risk populations; (2) identifying sensitive and specific human reproductive/deveiopmental end points and correlating them to exposure to Great Lakes contaminants; (3) determining the short* and long-term riskfs) of adverse health effects in progeny whose parents were exposed to Great Lakes contaminants; (4) investigating the feasibility of establishing registries and surveillance cohorts in die Great region; and (5) establishing a chemical mixtures database with emphasis on tissue and blood levels in order to identify new cohorts, conduct surveillance and health effects studies, and establish registries and surveillance cohorts. During FY1992, ATSDR announced a $2 million grant program to conduct research on the Impact on human health of contaminated fish consumption in the Great Lakes region. On September 30,1992, ATSDR announced nine awards under program. In FY 1993, about $3million was allocated to support the continuation of the research projects conducted at the nine institutions originally funded during FY 1992. far addition, ATSDR awarded one new grant to the Michigan Department ofPublic Health to design, establish, and operate a professionally creditable interlaboratory quality assurance/quality control program for the ATSDR Greet Lakes human health effects research program. ' F. OtherATSDR Programs in its role as a public health agency addressing environmental health, ATSDR may, where appropriate, collect human data to validate substancespecific exposure and toxicity finding*, information on levels of contaminants in humans ha* been identified as a priority data need for 37 of the 38 priority substances (Table 1). ATSDR will obtain this information through exposure and health effects studies, and through establishing and using subriancospedfic subregistries of people within the Agency's National Exposure Registry who have potentially been exposed to these substances. The list of 38 priority hazardous substances in the SSARP was forwarded to ATSDR's Exposure and Disease Registry Branch (EDRB), Division of Health Studies, for consideration as potential candidates for subregistries of exposed persons, based cm criteria described in EDRB's 1988 document, "Policies and Procedures for Establishing a National Registry of ' Persons Exposed to Hazardous Substances." To date, ATSDR has selected benzene, chromium, and trichloroethylene as primary contaminants to establish subregistries in the National Exposure Registry. However, aidrin/dieldrin, carbon tetrachloride, chioroethane, chloroform, cyanide, p,p'-DDT, DDE, ODD, di (2ethyihexyl) phthalate, mercury, methylene cnloride. PAHs, selenium, tetrachloroethylene, and vinyl chloride remain as a part of the candidate pooL They will be considered for selection as primary contaminants during each selection process (Table 1). Finally, arsenic, beryllium, cadmium, lead, nickel, PCBs, toluene, and zinc are not considered to be in the pool of candidate substances for an exposure registry at this time. This decision will be re-evaluated as more information on the chemicals and exposure sites become available. With regard to epidemiologic studies, ATSDR believes that for many of the 38 priority hazardous substances, an extensive amount of animal data, and some human data, have already been collected; therefore, ATSDR considers it appropriate, where feasible, to conduct epidemiologic studies an such substances. In response to public comments, the Agency's SSARP will address substance-specific rather than site-specific epidemiologicstudies. The substance-specific studies are designed to determine substancespecific cause and effect. In this case, ATSDR is not necessarily directed toward populations exposed via the environment at hazardous substance release sites, as in a site-specific study. Instead, any appropriate population of suitable exposure via the environment. consumer products, or occupation can be used to design a rigorous analytic epidemiologic investigation. Epidemiologic studies on several of ATSDR's 38 priority hazardous substances (such as DDT, PCBs. and PAHs) are being conducted by the ATSDR Great Lakes human health effects research program (Table 5). Two epidemiologic studies on lead (identified as a data need by ATSDR), are also being conducted by the Morehouse School of Medicine and the King/Drew Meffical Center of the Charles R. Drew University of Medicine and Science via the ATSDR--MHPF cooperative agreement ATSDR expects that other substance-specific epidemiologic studies, identified as data needs or priority data needs in the SSARP, may potentially be conducted by other Divisions within ATSDR. 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 ATSDR* sponsored auspices. Toward that end, tfes Agency encourages the private sector and 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 contaminated media around hazardous waste sites have been identified as priority data needs for all 38 priority hazardous substances by ATSDR However, the Agency realizes that a lot of information has already been collected through individual state programs and the EPA's CERCLA activities; therefore, ATSDR will evaluate the extant information from these programs in order to help fill data needs on substance-specific exposures. The results of the research conducted via the SSARP will be used for public health assessments and to reassess ATSDR's substance-specific priority data needs. The Agency expects to re evaluate the priority data needs for priority hazardous substances every threeyears. Dated: March 3,-1994. Wafer L Dowdk, DeputyAdministrator, Agencyfor Tad Substances andDisease Registry. R&S 144848 Federal Register / Vol. 59, No. 47 / Thursday, March 10, 1994 / Notices 11437 Table 1 .--Substance-Specific priority Data Needs currently Being addressed Under ATSDFrs applied Research programs Substance Lead / Arsenic Mercury / Vinyl Chloride / Benzene Cadmium , w' PCBs i Chloroform ______ PAHs E: Trichloroethytene. ID 1A IB 1C 2A 2B 2C 2D 3A 3B 3C 3> 3E 4A 4B 4C 4D 4E 4F 4G 5A SB 5C 5D 5E 6A 6& 7A 7B 7C 7D 7E BA SB 8C 80 M SB SC UD 9 9F 9G 10A tOB IOC 10D Priority Data Need Addressed Mechanistic studes on the neurotoxic effects of lead Analytical methods tor tissue levels Exposure levels in humans Swing near hazardous waste sites and other populations, such as exposed workers. Comparative toxicokinetic studes to determine ff an appropriate animal species can be identified. Half-lives to surface water, growdwater------------------------------------------ --............................. BtoavailabiBty from soil__ --...................................................................................... ........ .......- Exposure levels in humans living near hazardous waste sites and other populations, such as axposed workers. Mrflgsnetation reproductive taxicity study via oral exposure------------------------------------------- One-response data in animate lor chronio-duration oral exposure---------------------------------- Immunotoxicoiogy battery of tests via orai exposure............................ ........... --............-- Exposure levels In humans iving near hazardous waste sites and other populations, such as exposed workers. Potential canddate lor sutaregistry of exposed persons - .............. -..............-.......-- . . Dormreaponae data in eternals lor acuto-dreation inhaiatioo exposure ....... -.............. -- Multigenerafion reproductive toxicity study vie Miatebon----------------------------------------------- Pore-response data In animats tor chronio-rkxabon inhalation exposes........ .... ................ Mitigadonof vinyl chtoride-toduced toxicity-------------------------- .------- ,-------------------------------- 2-spedes devetopmentM toxidty study via inhatafloo....... ............ ....................;.............. -- Exposure leveiB in humans living near hazardous waste srtas and other populations, such ' as ogtosed workers. Potential canddate for subregistry of exposed persons - ......... ..........-............... - Doee-response data in arterial* foe acuta- and totetmedatedraalion oral etqMsure. The sttoctarenicstuifr should toduda an extended reproductive organ Nstcpathotogy. 2-spede* developmental toxicity study via oral exposure------ __-------------------------------------- > Neurotoxicology battery at tests via orai exposure_____ *................. ............................. Epidemiological studies on the health effects of benzene (Special emphasis endpoints in- -.duderimmunotoxIcKy). Exposure terete In humane living nere hazardous waste sites and other populations, such ' aa exposed workers. Analyficaf methods for biological tissues and ffuids and environmental meda................... -- Exposure levete fa humane IMng near hazardous waste sites and other populations, such wpotteo woyKgfB* Dree response data inanimate ter acute- and intermediate-duration oral exposures--------- - Biodegradation of PCBS in water bioavaiiability ol PCBs to air, water and soil..... --........... Doee response data in animate tor acute- and Wermedtete-duration inhalation exposures. The subchronic study should indude extended reproductive organ histopathoiogy. Eftetemtoiogfcaf studes on the health offsets of PCBs (Special emphasis endpoints include: immunotoxicity, gastroiritesttoai toxidty, her, kidney, ffiyreid toxidty, reprodudire/devei- opmentai toxidty>. Exposure levels' In humans Ivfog near hazardous waste sites and other populations, such as exposed workers. Pose-response data toartenate for intermediate-duration oral exposure......... -.............--, Epidemiological studes on theJwalth effects ol chloroform (Spedaf emphasis endpoints In- dude; cancer, neurotoxicity, reproductive and developmental toxidty, hepatotoxidty, and iwiBi loxicny* Exposure levete to humans Bring near hazardous waste sites and other popufaflona, such as exposed workers. Potential canddate tor subregbby ol exposed persons Dose-response date to animals tor intermediate duration oral exposures. The subchronic study should indude extended reproductive organ histopathoiogy and immunopathology. 2-spedes devetepmental toxidty study vtsktealtdon or ore! exposure ....... ......... ................. MechanLatiL studes on PAHs, on how mixtures of PAHs can influence the ultimate activa tion of PAHs, and on how PAHa affect rapkfy proliferating tissues. Doee-response data to animals tor acute- and intermedate-dUration inhalation exposures. The .subchronic study should indude extended reproductive organ histopathoiogy and tosnunopathotogy. Cf*ten*jto0cat studes on the health eftacte of PAHs (Special emphasis endpoints Include: cancer, ctermat hemofymphatic. and hepaOcf. Exposure levels in humans ihdng near hazardous waste sites and other populations, such as exposed workers. , Potential canddate for subregistry ol exposed persons - .................................. .................. Dose-response data in animals for acute-duration oraf exposue ....... Neurotnxicoiogy battery of tests via the oral route .............. .... Immunotoxicoiogy battery of tests via the oral route Epkterrtotojpcat studes on the health effects of trichloroethytene (Spedat emphasis endpoints indude: cancer, hepatotoxidty, renal toxidty. developmental toxicity, and negrotoxidty). V * * * R&S 144849 11438 Federal Register / Vol. 59, No. 47 / Thursday. March 10, 1994 / Notices Table 1 -Substance-Specific Priority data needs Currently Being addressed Under ATSDR's applied Research Programg--Continued Substance ID Priority Data Need Addressed DDT ... 10E 11A 11B TIC 11D 11E 11F v' Chromium____ ....___ _ 12A 12B 12C 12D 12E Tetrachloroethylene 13A 13B 13C 130 13E AWrin/Diekfrto 13F 14A 14B 14C 14D Cyanide ....----------------- ISA Carbon Tetrachloride Beryllium ______ ___ Toluene 15B 15C 15D 1SE IGA 16B 16C 16D 16E 17A 17B 17C 17D 17E 17F ISA Nickel 168 18C 180 18E 19A 19B 19C 19D 19E 19F Exposure levels in humans living near hazardous waste sites and other populations, such as exposed workers. Dose-response data in animals for chronic-duration oral exposure-------- -------------------------- Comparative toxicokinetic study (across routes/species)------------------------------------------------- Bloavailabiity and bioaccumulation from sol------------------------------------------------------------- Epidemiological studes on the health effects of DDT. D00 and DDE (Special emphasis endpoints include: immunotoxicity, reproductive and developmental toxicity). Exposure levels in humans living near hazardous waste sites and other populations, such as exposed workers. Potential candidate for sutxegistry of exposed persons----------------------------------------------Dose-response data in animals tor acute-duration exposure to chromium (VI) and (110 via oral exposure and for totermedate-duration exposure to chromium (VI) via oral exposure. Muttigenerctfon reproductive toxicity study via oral exposure torchromium (III) and (VI)-----Immunotoxicoiogy battery of tests following oral exposure to chromium (III) and (VI)---------- 2-species developmental toxicity study via oral exposure to chromium (III) and (VI) Exposure levels in humans living near hazardous waste sites and other populations, such as exposed workers. Dose-response data in animals for acute-duration oral exposure, including neuropathology and demeanor, and immunopathotogy. Multigeneration reproductive toxicity study via oral exposure----------------- .................. ....... .... Dose-response data In animals tor chronioduration oral exposure, including neuropathology and demeanor, and immunopathotogy. 2-species developmental toxicity study via oral exposure Exposure levels in humans living near hazardous waste sites and other populations, such as exposed workers. Potential candidate tor subregisfry of exposed persoos Dose-response data in animals tor intermediate-duration oral exposure Bioavailability from soil Exposure levels in humans living near hazardous waste Sites and other populations, such as exposed workers. Potential candidate for subregisfry of exposed persons . Dose-response data In animals tor acute- and intermediate-duration exposures via inhala tion. The subchronic study should include extended reproductive organ histopathoiogy and evaluation of neurobehavioral and neuropathoiogieal endpoints, 2-species developmental toxicity study via oral exposure Evaluation of the environmental fate of cyanide in soil Exposure levels in humans living near hazardous waste sites and other populations, such as exposed workers. Potential candklate for subregistry of exposed persons Dose-response data in animals tor chronic oral exposure. The study should indude ex tended, reproductive organ and nervous tissue (and demeanor) histopathoiogy. immunotoxicoiogy battery of tests via oral exposure Half-life in soil ______ _ Exposure levels in humans living near hazardous waste sites and other populations, such as exposed workers. Potential canddate tor subregistry of exposed persons________ ___ ___ ---____ ~~_____ Dose-response datato animals for acute- and totermedate-duration inhalation exposures. The subchronic study should indude extended reproductive organ histopathoiogy. 2-species developmental toxicity study via inhalation exposure___ __ ___ ...--._____ .____ Environmental late in air, (actors affecting bioavailability in air Analytical methods to determine environmental spedation ,, Immunotoxicoiogy battery of tests foltowing oral exposure Exposure levels in humans living near hazardous waste sites and other populations, such as exposed workers. Dose-response data to animals (or acute- and totermedate-duration oral exposures. The subchronic study should include an extended histopathological evaluation of the immune system. Comparative toxicokinetic studies (Characterization of absorpttoa.distributiorv and excre tion via oral exposure). Neurotoxicology battery of tests via oral exposure -............ - -..........Mechanism of toluene-induced neurotoxicity -- -- Exposure levels to humans living near hazardous waste sites and other populations, such as exposed workers. Epidemiological studies on the health effects of nickel (Special emphasis endpoints include: reproductive toxicity). 2-spedes developmental toxicity study via the oral route Dose-response data to anfrnais for acute- and intermediate-duration oral exposures Neuretoxicoiogy battery of tests via oral exposure : .................................. ... Btaavailablltty of nickel from sofl Exposure levels to humans living near hazardous waste sites and other populations, such as exposed workers. * V * * * r 20 CO U 00 Ol o Federal Register / VoL 59. No. 47 / Thursday. March 10. 1994 / Notices 11439 Table i.--Substance-Specific Priority data needs Currently Being addressed Under ATSDR's applied Research Programs--Continued Substance Methylene Chloride Zinc -----------------DEHP ------------------ Selenium. ID 2QA 20B 20C 20D 21A 21B 2TC 21D 22A 22B 22C 22D 22E 22f 23A 23B 23C Priority Data Need Dose-response data in animals, lot acute- and intermediate-duration oral exposure. The subchronic study stated Include extended reproductive organ histopathology. neuropathology and demeanor, and. Immunopathology. 2-spedes developmental toxicity study via the oral route Exposure levels in humans living near hazardous waste sites and other populations, such as exposed workers. Potential candidate for sibregistiy ol exposed persons Dose-response date in animals tor acuta- and intermediate-duration oral exposures. The sttochronic study should include an extended, histopathotogicat evaluation of the immunologic and neurotogicat systems. Multigeneration reproductive toxicity study via oral exposure---------------------------------.-- Carcinogenicity tearing (2-year bioassay) via oral exposure Exposure levels In humans living near hazardous waste sites and other populations, such as exposed workers. Epidemiological stucfes on the health effects ol DEHP {Special emphasis endpoints in clude: cancer). Dose-response data in animals for acute- and intermediate-duration oral exposures. The subchronic study should indude an extended histopaihoiogical evaluation of the immunologic and neurologic systems. MuftfgsneraOon reproductive toxtaty study via oral exposure Comparative toxicokinette stucfes (Stucfes designed to examine how primates metabolize and distribute DEHPas compared to rodents via oral exposure). Exposure levels in Itumans fving near hazardous waste sites and other populations, such es exposed workers. Pdenflaf eanefdate forsubregfetry of exposed persons Dose-response data in animals lor.acute-duration oral exposure Immunotoxicology battery of tests via oral exposure Epidemiological stucfes on the health effects of selenium (Special emphasis endpoints in clude:, cancer, reproductive and developmental toxicity, hepatotoxidty and adverse skin Addressed * Chloroethane -- 23D 23E 24A 24S 24C Exposure levels in humans riving near hazardous waste sites and other populations, such ae exposed woritare. Potential candidate for subregistry of exposed persons Dose-response data in animate lot acute- and Intermediate-duration oral exposures. The subchronte study should include an evaluation ol immune and nervous system (and be havior, demeanor) tissues, and extended reproductive organ Wstopathotogy. Ttoe-responre date to animate to chronic inhalation exposures. The study should include an evaluation ci nervous system- (and behavior) tissues. Potential candidate to stexegistry oi exposed persons ----------------------------------------- %r These substances are iridUded in the pooled candHate substances forstfcregfetry development These stastances will be considered for i lection as primary contaminants by the Division of f leeitfi Stucfes, ATSDR. during each selection process. * Table 2.--priority Data Needs Being Addressed by EPA Rule making fiiihatamt Mercury ____ Vinyl Chloride Benzene ...-- ID 3B 3C 46 4E 5A Trichloroethylene. y Chromium_____ _ SC 10A IOC 12A 12B 12C Tetrachioroethytene ____ - 13A Si 13B 13D Priority Date Need TSCA/HFRA Ooaarespoose date to animals to chrontockxation oral exposure Immunotoxicology battery of tests via oral exposure Mutrigeneradon reproductive toxicity study via inhalation 2-speciea ctevelopmantal toxicity study via inhalation -- DosMMponse- date In animate to intermediate-duration real exposure.' The subcbronic study should Include an extended reproductive organ hfetopattalogy. Neurotoxicology battery ol teste via oral exposure Dose-response date to animate to aeteaduration oral exposure. Immunokadcology battery of teste via the oral route Dorn response date In animate to acuto-duratinn expcaure to cteomium(VI) and (111) via oral exposure Muftigeneretian mproteidMO toxicity study uto oral exposure to chromium (III) and (VI), Immunotoxicology battery of teste following oral exposure to chromium (III) and (VI) -- Dose-response date in animate to acuteduratioa oral exposure. Including neuropathology and dameanot. and karaunopetholnoy. Multigeneration reproductive toxicity study via oral exposure-------------------------------- --- 2-Spectes developmental toxicity study via oral exposure, TSCA. TSCA. TSCA. TSCA. TSCA. * TSCA. TSCA. TSCA. TSCA. TSCA. TSCA. TSCA (inhalation study). TSCA (inhalation study). TSCA to*). R&S 144851 11440 Federal Register / Vol. 59. No. 47 / Thursday. March 10, 1994 / Notices Table 2.--Priority Data needs Being Addressed by EPA Rule Making--Continued Substance Cyanide..... . . ID ISA 15B Beryllium ________.... ISC 17A 17B 17C 17E Tducn6 18A 1.8B Methylene Chloride______ 2QA 20B Chloroethane____________ 24A Priority Data Need TSCA/F1FRA Dose-response data in animals for acute- and intermertiateduration exposures via in halation. The subacute study should include extended reprai*jctive organ histopathology and evaluation of neurobehavioral and neuropathological endpoints. 2-Spedes developmental toxicity study via oral exposure --....................... ......-......... Evaluation of the environmental late of cyanide in soil .......... ........... .....--....... ........ Dose-response in animals tor acute- and mtermedtote-duration inhalation expo- sure*. The subchronic study should include extended reproductive organ histopathology. 2-species developmental toxicity study via inhalation exposure .......................... ......... Environmental fate in air; factors affecting bioavailability in air---------------------------------- Immunotoxicotogy battery of tests following oral exposure--------------------------------------- Dose-response data in animals for irrtefmediateduration oral exposures. The study. should include an extended histopathological evaluation ol the immune system. Comparative toxboldnetic studtos (Characterization of absorption, dstribution, and axcretion via oral exposure). Dose-response data in animals for Mermedate-durfcbon oral exposure. The study should incHxte extended immunapattiofogy and neuropathology. 2-species developmental toxidty study via the oral route------------------------------- - Dose-response data In artmais for acute- and Intermedtate-duration oral exposures. The subchronic study should include an evaluation ot immune and nervous system (and behavior, demeanor) tissues, and extended reproductive organ histopathology. TSCA TSCA (inhalation study). TSCA TSCA TSCA TSCA TSCA (inhalation study). TSCA TSCA TSCA TSCA TSCA (EPA will only address the immune system requirement of this Priority Data Need) Table 3.--Priority data needs Potentially Being Addressed by Voluntary Research Substance ID PCBs... ............................. 78 7E Methylene chloride ..1_____ 20A 208 Priority data need Firm fUnrWjra/fctfinA n# PCA* fat antai ..... .... ...... Epidemiological etudes on the health effects of PCBs (Special eropriasis endpoints include; Immunotoxicity. gastrointestinal, toxidty, Iver, kidney, thyfoid, toxicity, reproductive/developmental. toxicity). Dose-response data in animals for acute- and intermedate-duretion oral exposure. The subchronic study should include extended re productive organ histopathology. neuropathology and demeanor, and immunopathotogy. 2-species developmental toxidty study via the oral route ---- General Electric Company. General Electric Company. . Halogenated Solvents Industry Alliance. Halogenated Solvents Industry Alliance. Table 4,--Priority data needs Being addressed by MHPF Institutions Substance ID Lead -- ___ 1A 1C Mercury ,, v/ Benzene. 3A 58 PAHs......................... 9A 9D Trichloroethylene_____ 106 Priority data need Institution Mechanistic studies on the neurotoxic effects of lead ... Exposure levels in humans living near hazardous waste sites and other populations, such as exposed workers. , Multigeneration reproductive toxidty study via oral ex- posure. 2-species developmental toxicity study via oral expo sure. Dose-response data kranimals for Intermedate dura tion oral exposures. The subchronic study should in clude extended reproductive organ histopathology and immunopathotogy. Dose-response data in animals for acute- and inter- medate-duration inhalation exposures. . The tubchrorac study should include extended reproduc tive organ histopathology and Immunopathotogy. Neurotoxicoiogy battery of tests via oral exposure------ Florida A & M University. Texas Southern University. The King/Drew Medfoal Center of the Charles Drew University of MecSdne and Science. Morehouse School of Medicine. Tuskegee University. Xavier University. Meharry Medcal College. Meharty Medical College. Texas Southern University. Ft 00 cn to R&S * r Federal Register / Vol. 59, No. 47 / Thursday. March 10. 1994 / Notices 11441 Table 4.--Priority data Needs Being Addressed by MHPF Institutions--Continued Substance ... . 7inc......... 1 ID 18C 21A Priority data need institution Neurotoxicology battery at tests via oral exposure------Dose-response data in animals for acute- and inter- medtatedurebon oral exposures. The subchronic study should include an extended histopathoiogical evaluation of the immunologic and neurological sys tems. Texas Southern University. Xavier University. Tusfcegee University. Table 5.--Priority Data Needs Being Addressed by the ATSDR Great lakes human Health Effects RESEARCH PROGRAM Substance ID Priority data need Institution 1 68^ ........................ !............. 1C Mercury --__________ 3A 3D 3E PCBs-------------- ---------- 7A 7E 7F PAHs___________ 9E 9F DDT ----- -------------------- 11D 11E 11F Exposure levels In humans living near hazardoua waste sites and other populations, such as ex posed workers. State University of New York at Buffalo. State University of New York at Oswego. Michigan State University. University of Wisconsin-Superior. New York State Health Department University of Illinois at Chicago. University of Illinois at Uibana-Champaign. Wisconsin Department of Health and Social Services. Multigeneration reproductive toxicity study via oral exposure. Exposure, levels in humans living near hazardous waste sites and other populations, such as exposed workers. State University of New York et Oswego. University of Illinois at Chicago. State University of New York at Buffalo. State University of New York at Oswego. Michigan Stale University. University ot Wisconsin--Superior. New York State Health Deportment University of Illinois at Chicago. University of IBinois at Urbana-Champaign. Wisconsin Department of Health and Soda! Services. Potential candidate for subregistiy of Wisconsin Department of Health and Social Services. exposed persons. Dose-response data in animals for University of Wisconsin--Superior, acute- and Intermediate-duration oral exposures. Epidemiological studes on the health State University of New York at Buffalo. effects of PC8s (special emphasis State University of New York at Oswego. endpoints include: immunotoxtoty. University of Wisconsin--Superior. gastrointestinal toxicity, liver, kid University of Illinois at Chicago. ney, thyroid toxicity, reproductive/ University of Illinois at UrbaraChampaign. developmental toxicity). Exposure levels in. humans living State University of New York at Buffalo. near hazardous waste sites and State University of New York at Oswego. other populations, such as ex Michigan state University. posed workers. f University of Wisconsin--Superior. V New York State Health Department University of Illinois at Chicago. University of Illinois at Urbana-Champaign. Wisconsin Department of Health and Social Services. Epidemiological abides on the health Wisconsin Department of Health and Social Services. effects of PAHs (special emphasis endpdnts include: cancer, dermal, hemotymphatip. and hepatic). Exposure levels In humans living Wisconsin Department of Health and Social Services. near hazardous waste sites and other populations, such as ex posed workers. Epidemiological studies on the health State University of New York et Buffalo. effects of DOT. DDD and DDE State University of New York at Oswego. (special emphasis endpoints. In Michigan State University. t clude: knmunotoxidty, reproductive University of Illinois at Chicago, and developmental toxicity). Wisconsin Department of Health and Social Services. Exposure levels in humans living State University of New York at Buffalo. near hazardous waste sites and State University of New York at Oswego. other populations, such as ex Michigan State University. posed workers. University of Illinois at Chicago. Wisconsin Department of Health and Social Services. Potential candidate for subregistry of Wisconsin Department of Health and Social Services. exposed persons. ' (FR Doc. M-S555 Filod 3^9-44; 8:4S am] R&S 144853