Document ba1wdaEqndYeLjNmN26Er2OrZ

11434 Federal Register / Vol. 59, No. 47 / Thursday, March 10, 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 announces that research has been for filling a broader range of data needs. Agency for Toxic Substances and initiated for a specific data need. CERCLA, in section 104(i)(5)(D), v' Disease Registry ADDRESSES: Private sector organizations states that it is the sense of Congress [ATSDR-79J Status of the Superfund SubstanceSpecific Applied Research Program interested in volunteering to conduct* this type of research may write to Dr. William Cibulas, Chief, Research Implementation Branch, Division of that the costs for conducting this research program be borne by the manufacturers and processors of the hazardous substances under the Toxic AGENCY: Agency for 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'a 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 for Toxic Substances and Disease Registry, Mailstop E-29.1600 Clifton Rood, NE^. Atlanta, Georgia 30333. FOR FURTHER INFORMATION CONTACT: Dr. William Cibulas, Chief, Research Implementation Branch, Division of Toxicology, Agency for Toxic Substances and Disease Registry, Mailstop E-29,1600 Clifton Road. NE-, Atlanta. Georgia 30333, telephone (404) 639-6306. SUPPLEMENTARY INFORMATION? Background Substances Control Act (TSCA) and by registrants under the Federal Insecticide. Fungicide, and Rodentidde Act (F1FRA), 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 via regulatory mechanisms (TSCA/FIFRA). private sector voluntarism, and the direct use of CERCLA funds. A Tri-Agency Superfund Applied Research.Committee (TASARC) comprised of scientists from ATSDR, NTP, and the EPA has been set up to-. (1) Advise on the assignment of Reauthorizstion Act (SARA) (42 U.S.C. 9604 (i)), was initiated on October 17, 1991. At that time, a list of priority data needs for 38 priority hazardous substances was announced in the Federal Register (56 FR 52178). The list The Comprehensive Environmental. Response, Compensation, and Liability Act of 1980 (Superfund) or CERCLA, aa amended by the Superfund Amendments and Reauthofixation Act (SARA) [42 U.S.C. 9604(1)], requires that priorities on mechanisms for filling data needs; (2) coordinate knowledge of research activities to avoid duplication of research in other programs and under other authorities; (3) advise on issues of science related to substance-specific was subsequently revised based on public comments, and published in ATSDR (1) Jointly with the Environmental Protection Agency data needs; and (4) maintain a scheduled forum that provides an final form on November 16,1992 (57 FR 54150). The 38 substances, each ofwhich is (EPA), develop and prioritize a nst of hazardous substances found at National Priorities list (NPL) sites, (2) prepare overall review of the ATSDR SSARP. The TASARC has met four times since the initiation of the SSARP. This notice found on ATSDR'a "List ofPriority Hazardous Substances"' (56 FR S21A6, October 17,1991), are aRtrin/dieldrin, toxicological profiles for these substances, and (3) assure tho initiation of a research program to fill identified Exrides the status of ATSDR's efforts to plement the SSARP, focussing on ongoing activities relevant to test rule arsenic, benzene, beryllium, cadmium, data needs associated with the development under TSCA/FIFRA, carbon tetrachloride, chkaoethane, substances. Before starting such e private sector voluntarism, and direct chloroform, chromium, cyanide, p.p'- program, ATSDR will consider use of CERCLA funds. Additional data DDTJDDEDDD, di- recommendations of the Interagency needs are being addressed through an etbylbexyDphtbalate, lead, mercury, Testing Committee established under interagency agreement with NTP, by methylene chloride, "frfad. section 4(e) of the Toxic Substances ATSDR's Great Lakes human health polychlorinated biphenyl compounds Control Act on the type of research that effects research program, and other (PCBs), polycyclic aromatic hydrocarbons (PAHs) (includes 15 should be done. ^ On October 17,1991, ATSDR Agency programs. To date, 59 priority data needs associated with 35 ATSDR substances), selenium, announced tbs identification of the priority hazardous substances tetrachloroethylene, toluene, priority data needs for 38 priority - (including 15 PAHs) are being trichloroethylene, vinylchforide, and hazardous substances (56 FR 52178), addressed via these mechanisms (Table zinc. This notice also serves as a continuous call for voluntary research requested public comments, and invited 1). private sector organizations tovolunteer to conduct research to fill specific A. TSCA/FIFRA initiatives. ATSDR encourages private priority data needs. On November IS, b 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 data needs. A Tri-Agency Superfund priority hazardous substances (57 FR established procedures to identify priority data needs of mutual interest to Applied Research Committee (TASARC) 54150). Federal programs. These data needs will comprised of scientists horn ATSDR, The major goals 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 Environmental Protection information needs of the public and portion of the research will be Agency (EPA) will review all proposed voluntary research efforts. scientific community, ana (2) to supply conducted according to established information necessary to conduct TSCA procedures and guidelines. This DATES: ATSDR considers the voluntary comprehensive public health 1 testing will fulfill more than one Federal research effort to be important to the assessments of populations living near program's need. During FY 1993, a continuing development of the SSARP. hazardous waste sites, lids 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 to volunteer generalized to other substances or areas the EPA under its authorities following CMA 113600 I Federal Register / Vol. 59, No. 47 / Thursday, March 10, 1994 / Notices ----------i----rni^mm------ 11435 review and endorsement by the TASARC oversight committee. Currently, 26 priority data needs associated with 11 ATSDR substances have been recommended by EPA to be added to its Master Testing list, the first step in test rule development under TSCA, section 4 (Table 2). Please note that although ATSDR has identified priority data needs for oral exposure to tetrachloroethylene, cyanide, and beryllium, in response to other Federal government agency needs, ATSDR will consider proposals to conduct inhalation studies in conjunction with pharmacokinetic studies for these 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 PAH*, because the PAHs are by products of multiple industrial processes and, therefore, it is difficult to identify specific manufacturers. In addition, TSCA guidelines an not available for some of the ATSDR priority data needa such as the development of analytical methods for cadmium and beryllium, mechanistic studies on the neurotoxic effects of lead, and the mitigation of toxicity of vinyl chloride. Moreover, some of the ATSDR priority hazardous substances are . considered more appropriate for FtFRA than TSCA, e.g., arsenic. DDT, and aldrin/dieldrin. The Office of Pollution, Prevention and Toxics (OPPT), EPA, forwarded the data needa for these substances to the Office ofPesticide Programs for evaluation. B. Private Sector Voluntarism As part of the SSARP, ATSDR initially announced a set ofproposed procedures for conducting voluntary research on February 7,1992 (56 FR 4758), It was revised based on public comments and published on November 16,1992 (57 FR 54160). Ibis voluntary research program fills priority data needs along with other mechanisms such as test rule development through EPA and CERCLA-funded research. Private sector organizations were encouraged to volunteer to conduct . research to fill these specific priority data needs. Currently. ATSDR is pursuing minority citizens. The purposes of the voluntary research interests with two ATSDR-MHPF cooperative agreement private sector organizations: the General are: (1) To initiate research to fill Electric Company (GE) and the ATSDR-identified date needs for Halogenated Solvents Industry Alliance priority hazardous substances, and (2) to (HSIA). To date, through the voluntary enhance existing disciplinary capacities research efforts of GE and HSIA, four to conduct research in environmental priority data needs for two substances health at MHPF member institutions. are under discussion, potentially The areas of research at MHPF leading to the signing of two institutions include those related to memorandums of understanding (Table 3). During FY1993, ATSDR staff broad areas of toxicology and environmental health science. Some of the MHPF member institutions are members met with officials from GE to conducting health studies of minority discuss the Agency's research agenda groups exposed to ATSDR's priority for PCBs. The Agency has identified hazardous substances. 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 discuss the use of physiologically-based pharmacokinetic (PBPK) models to fill priority date needs D. National Toxicology Propxun ATSDR maintains an interagency agreement (1AG) with NTP to conduct toxicological testing at substances identified at NFL sites. The studies determine levels ofexposure that present a significant risk to humans of for six volatile organic compounds. The acute, subacute, and chronic health Agency selected methylene chloride to effects. Often these studies include an start using PBPK modeling to address assessment of the substance's ability to ATSDR's toxicity priority data needs cause cancer, reproductive toxidty, and because of the extensive database on birth defects. The results of these this substance. The toxicity priority data studies are used by regulatory agencies needs for the remaining 5 volatile such as tbs Food and Drug organic compounds (carbon Administration and the EPA, various tetrachloride, chloroethane, chloroform, environmental and industrial groups, tetrachloroethylene. and and ATSDR to improve the ability to trichloroethylene) may be addressed via conduct public health assessments at similar voluntary efforts in the future. NPL sites. Under this agreement, one C. CERCLA-Funded Research fMinority toxicity priority data need identified in .the SSARP (carbon tetrachloride, Health Professions Foundation Research immunotoxicology battery of tests via Program) oral exposure) is currently being During FY 1992, ATSDR announced e addressed. This NTP study wasbegun $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 ' E. Great Lake* Human Health Effects investigations. This cooperative venture Research Program is supported by the dined use of Some of the priority date needs GERCLA funds. During FY 1993, about identified in the SSARP have been S4 million was allocated to continue independently identified as research this research program: no new projects needs through the ATSDR Great Lakes were initiated. Currently, 9 priority data human health effects research program, needs for 21 priority hazardous a separate research program. To date, 12 substances (including 15 PAHs) in the priority data needs for 19 priority SSARP are being addressed by the hazardous substances (including 15 MHPF institutiona through this PAHs) identified in the SSARP are being program. Also, the MHPF research addressed through this program. The program will address 13 other institutions receiving swards and their substance-specific data needs identified respective studies are listed in Table 5. in the ATSDR toxicological profiles The Great Lakes Critical Programs Act concerning exposures and related health of 1990 mandates EPA, in consultation effects. The institutions receiving with ATSDR, to prepare a report by awards and their respective research September 30,1994, that assesses the protects are listed in Table 4. advene effects of pollutants in the Great The MHPF, a not-for-profit 501(c)(3) Lakes system on the health of organization, is comprised of 11 individuals in the Great Lakes states. A minority health professions schools. Its variety of persistent toxic substances are primary mission is to research the prevalent in the Great Lakes, including persistent health problems that PCBs, DDT and its metabolites, dieldrin, disproportionately plague poor and toxaphene. minx, mercury, CMA 113601 11436 Federal Register / Vol. 59, No. 47 / Thursday. March 10, 1994 / Notices benzo[a]pyrene. bexachlorbbenzene, priority data need for 37 of the 38 consumer products, or occupation can fuians, dioxins, and lead. Certain priority substances (Table l). 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 (such as DDT, PCBs, and higher risk of long-term adverse effects people within the Agency's National PAHs) are being conducted by the resulting from exposure to these Exposure Registry who have potentially ATSDR Great Lakes human health contaminants. been exposed to these substances. effects research program (Table S). The ATSDR-supported research The list of 38 priority hazardous Two epidemiologic studies on lead projects focus on these high-risk substances in the SSARP was forwarded (identified as a data need by ATSDR), populations to try to further define the to ATSDR's Exposure and Disease are also being conducted by the human health consequences of exposure Registry Branch (EDRB), Division of Morehouse School of Medicine and the to these persistently toxic substances. Health Studies, for consideration as King/Drew Medical Center of the The research activities include, but are potential candidates for subregistries of Charles R Drew University of Medicine not limited to: (1) Characterizing exposed persons, based on criteria and Science via the ATSDR--MHPF exposure and determining the profiles described in EDRB's 1988 document, cooperative agreement. ATSDR expects and levels of Great Lakes contaminants "Policies and Procedures for that other substance-specific in biological tissues and Quids in high- Establishing a National Registry of epidemiologic studies, identified as data risk populations; (2) identifying Persons Exposed to Hazardous needs 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 short- and long-term riskfs) of advene health effects in progeny whose parents were exposed to Great Lakes contaminants: (4) Investigating the feasibility of establishing registries and surveillance cohorts in the Great Lakes 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 52 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 this 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. In addition, ATSDR awarded one new grant to the Michigan trichloroethylene aa primary contaminants to establish subregistries in the National Exposure Registry. However, aldrin/dieldrin. carbon tetrachloride, chloroethane, chloroform, cyanide, p,p'-DDT, DDE, DDD, di (2ethylhexyl) nhthalate, mercury, methylene chloride, PAHs, selenium, tetrachloroethylene. and vinyl chloride remain aa 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 he 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, hove already been collected; therefore, ATSDR considers it 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 ATSDRsponsored auspices. Toward that end, the 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 kaeUk (aeiiM 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 end the EPA's CERCLA activities; therefore, ATSDR will evaluate the extant information from Department of Public Health to design, appropriate, where feasible, to conduct these programs in order to help fill data establish, and operate a professionally epidemiologic studies on such needs on substance-specific exposures. creditable interlabontory quality assurance/quality control program for the ATSDR Gnat Lakes human health effects research program. F. Other ATSDR Programs In its role as a public health agency addressing environmental health, ATSDR may, when appropriate, collect substances. In response to public comments, the Agency's SSARP will address substance-specific rather than site-specific epidemiologicstudiea. The substance-specific studies are designed to determine substancespecific cause and effect. In this case, ATSDR is not necessarily directed toward populations exposed vis the The results of the research conducted via the SSARP will he 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 three years. human data to validate substance- environment at hazardous substance Dated; March 3,1994. specific exposure and toxicity findings; release sites, as in a site-specific study. Walter RDowtfle, information on levels of contaminants Instead, any appropriate population of DeputyAdministrator, Agencyfor Toxic in humans has been identified as a suitable exposure via the environment. Substances and Disease Registry. CMA 113602 Federal Register / Vol. 59, No. 47 / Thursday, March 10, 1994 / Notices 11437 Table 1.--Substance-Specific Priority Data Needs Currently Being addressed Under ATSDR's Applied research Programs Substance Lead...........------ y Arsenic Mercury .............. Vinyl Chloride , Benzene * Cadmium , PCBs..... Chloroform ... PAHs_________ Trichloroethylene, ID 1A IB 1C 2A 2B 2C 2D 3A 3 3C 3D 3E 4A 4B 4C 4D 4E 4F 4G 5A SB 5C 50 5E 6A SB 7A 7B 7C 7D BA 88 SC 8D M 98 9C 90 9E 9F 9G 10A tOB TOC 10D Priority Data Need Addressed Mechanistic studes on the neurotoxic effects of lead Analytical methods for tissue levels Exposure levels in humans living near hazardous waste sites and other populations, such as exposed workers. Comparative toxicokinetic studes to determine B an appropriate animal species can be identified. Hail-ttvea in surface water, groundwater - .....-- ....................- ,,,------------------- ------- BioavaiiabiEty from soil Exposure levels in humans living near hazardous waste sites and other popUabons, such as exposed workers. Multigeneration reproductive toxicity study via oral exposure Dose-response data in animals for chronto-dtsatlon oral exposure Immunotoxicoiogy battery of tests vie oral exposure Exposure levels In humans living near hazardous waste sites and other populations, such as exposed workers. Potential canddate for subregistry of exposed persons___________ ....___ --_.------ ,, Dose-response date in animate for acute-dureiion inhalation exposure __------------------- -- Mulbgensrabon reproductive toxicity study via inhalation , Dose-resporae data to arxmale for thronlc-tkealion inhnidion exposure Mitigation of vinyl chkxkteindaedtoxidty 2-species development texidty duty vie WateOon Exposure lewete in humans living new hazardous end ottwr populations, such Potential candidate tor subregistry o( exposed Doseresponse date in erimais for acute- and Intermediate-duration oral exposure. The sttodsonfc study diould Include an extenrted reproductive organ hiaiopathotogy. 2-spectes developmental toxicity study vte oral exposure______________________ Naurotoxiootogy battery of teats vie oral exposure Epidemiological studies on the health effects of benzene (Specter emphasis endpoints in. dude: ImmunoCPxiflty). Exposure leuete in humane Hvtng near hazardous waste sites and other populations, such as exposed worker*. Andyficsf methods far btologfcd teams d HUMS and environmental made Exposure teveli in humans Irving near hazardous waste sites and other poputeMont, such as exposed worker* Dose response date to animate ter acute- and totormedatedurationorel exposures Biodegradation of PCBS in water; bioevafiability of PCBe in air, water and soil Dose response date In animate tor acute- and totormedsto-dkeatton Inhalation eigjosures. The tubcteonie study shoukf include extended reproductive organ histopathoiogy. Epktemioiogfcaf studfes on the health eftocfs of PCBs (Special emphasis endpoints include: immunotoKicity. gastrointestinal togdcNy, lie, kidney, thyroid toxicity. reprodJCtrvWdevet- PnioiWBi roocHyy. Exposure levels in humane Hvtng near hazarttous waste sites and other populations, such as expoeed worker* Dose-response date in anftnete tor kitermsdatedumtion end exposure Epktemiotogicat studies on the health effects of chlorotorm (Spectef emphasis endpoints in- duds: cancer, neurotoxicity, reproductive and developmental toxicity, hepetotoxWty, and rvnv VOXtCnf% Exposure terete in furmns iMng nmr hazardous waste sites and other populations, such tetxpowdwoitefit r uwiusi cantma for suoreQistry or oxposocr persons Doee-response data to animste tor totermedtete duration oral exposure* The titochronic study shodd include extended reproductive organ histopathoiogy and immunopatiology 2-spsdn devetopmental toxicity study via Halation or oral exposure Mecftantofc studes on PAHS', on how mixtures of PAHs can influence the ultimate activa tion of PAH* and on how PAHs affect rapidly proliferating tissue* Doee response date to animats tor acute- and totermedtetB-durattcn inhalation exposures. The tubchronic study should Include extended reproductive organ histopathotogy and tosnuncpalhotogy. E^demtotogicat studies on toe health effects of PAHs (Special emphasis endpoints Include: cancer, dermal. hemofymphatic. and hepatic}. Exposure levels In humans living near hazardous waste sites and other populations, such as exposed worker* Potential canddate for subcegteby of exposed persons Dose-responss data in animals for actde-durafibn oraf exposure NeurXoxteology battery of tests vta the oral route___________ _ Immunotoxicoiogy battery of tests via the oral route Epktomiotogtoat studes on the health effects of trichloroethylene (Sped* emphasis endpoints Indude: cancer, hepatotoxidty, renal toxicity, devetopmental toxicity, and neurotoxicity). * r' * * CMA 113603 11438 Federal Register t Vol. 59, No. 47 / Thursday, March 10, 1994 / Notices Table i .--Substance-Specific priority Data Needs Currently Being Addressed Under ATSDR's applied Research Programs--Continued Substance ID Priority Data Need Addressed tOE DDT............................. 11A TIB 11C 110 11E 11F Chromium.................... 12A 12B 12C 12D 12E Tetrachtoroethylene .... 13A 13B 13C 13D 13E AWrin/Dieldrin...... r...... 13F 14A 148 14C 14D Cyanide....................... 15A . 15B 15C 15D 15E Carbon Tetrachloride ... ISA 16B 16C 16D 16E Beryllium ..................... 17A 17B 17C 17D 17E 17F Toluene---------- -------- 18A 168 18C 16D 186 Nickel ......... ................ 19A 19B 19C 190 19E 19F Exposure levels m humans living near hazardous waste sites and other populations, such as exposed workers. Dose-response data in animats for chronic-duration oral exposure ....... ------------ ------------- Comparative toxieokinetic study (across routes/species)........ ................................................ BJoavrailabilty and bioaccumulation from soti______ ..-- .....................------ ------------------- Epidemiological stocSes on the health effects of DDT. 000 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 candklate for subregistry of exposed persons.......... ............................................... Dose-response data in animals lor acute-duration exposure to chromium (VI) and (III) via oral exposure and lor mtarmedtate-duration exposure to chromium (VI) via oral exposure. Muftigeneration reproductive toxicity study via oral exposure to chromium (III) and (VI)..-- Immunotoxtooiogy battery ol tests following oral exposure to chromium (III) end (VI) --.-- 2-spedes developmental toxicity study via oral exposure to chromium (III) and (VI) ---------Exposure levels m humans living near hazardous waste sites and other populations, such as exposed workers. Dose-response data in animals tor acute-duration oral exposure, tndudtog neuropathology and demeanor, and immunopathotogy. Muttigeneratlon reproductive toxicity study via oral exposus --............. ......... ----------- - Dosrwesponse data in animals tor chronioduration oral exposure, Indudtog neuropathology and demeanor, and immunopathotogy. 2-spedes developmental toxicity study via oral exposure------ ---------- ----------- ------------- Exposure levels in humans living near hazardous waste sites and other populations, such as exposed workers. Potential candklate tor subregistry ol exposed persons------------------ -------- --------------------- Dose-response data In animate for intermediate-duration oral exposure------ --------- --- Bioavailability from son ---------------- --...-------- ------ ~-------------------- ------ ----..... 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 animate tor acute- and kitermetiate-duration exposures via inhale- lion. The subchronic study should include extended reproductive organ histopathoiogy and evaluation of neurobehavtoral and neuropathoiogical endpoints. 2-spedes developmental toxicity study via oral exposure -............................... ..................... Evaluation of the environmental late of cyanide in soil---------.----------- ------- --------- ------------ Exposure levels in humans living near hazardous waste sites and other populations, such as exposed workers. Potential candidate for subregistry of exposed persons................. ...................... ...........-- Dose-response data in animate tor chronic oral exposure. The study should include ex- tended reproductive organ and nervous tissue (and demeanor) histopathoiogy. Immunotoxtooiogy 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 candklate lor subregistry ol exposed persons _____ _______________ --........ Dose-response data in animate tor acute- and intermedute-duratton inhalation exposures. The subchronic study should include extended reproductive organ histopathoiogy. 2-spedes developmental toxicity study via inhalation exposure____ _______________ Environmental late in air, factors affecting bioavailability in air ---------------------- -------- --- Analytical methods to determine environmental spedation..... .............................--.--TM Immunotoxtooiogy battery of teste following oral exposure.................. ..............------------ Exposure levels in humans living near hazardous waste sites and other populations, such as exposed workers. Does rasponse data In animate tor acute- and intermediate-duration oral exposures. The subchronlc study should include an extended htetopsthdogtoal evaluation ol the immune ConqKratfve toxieokinetic studies (Characterization of absorption, distribution, and exere- tton via oral exposure). Neurotoxicology battery of tests via oral exposure------ ......---------- ...-- -- Mecharwm of toluene-induced neurotoxicity -------------------------------- ---.. Exposure levels in humans living near hazardous waste sites and other populations, such as exposed workers. Epidemiotogicai studies on the health effects of nickel (Special emphasis endpoints include.' reproductive toxicity). 2-spedes developmental toxidty study via the oral route................... ....................... ....-- Dose-response data in animate for acute- and intermediate-duration oral exposures ...--.. Neurotoxicology battery of tests via oral exposure......... ................... ...................------ BtoaveBability ol nickel from soil -- _____ ' ----------- --------- ---------- - ----------- Exposure levels in humans living near hazardous waste sites and other populations, such as exposed workers. ' * * rT - CMA 113604 Federal Register / VoL 59, No. 47 / Thursday, March 10, 1994 J Notices Table i .-Substance-Specific Priority Data Needs Currently Being Addressed Under ATSDR's applied Research Programs--Continued Substance ID Priority Data Need Addressed Methylene Chloride 20A Ooee-response data i animals tor acute- and intemiediatedieatton oral exposure. The subchronic study thodd include extended reproductive organ htetopathdogy. neuropathology and demeanor, and iramunopattiotogy. 20B 2-speaea developmental toxicity study via the oral route................. .................... ................ 20C Exposure levels in humans living near hazardous waste sites and other papulations, such as exposed workers. 20D Potential candidate tor subregistry o(exposed persons..................... ....... ......... ................. Zinc 21A Dose-response data in arvmab tor aetee- and intermediate-duration oral exposures. The subchronic study should inducts an extended histopaihntogical evaluation of the immunologic and neurological systems. 21B Multigeneration reproductive toxidty study via oral exposure --.......... .......--....... ............ 2TC Carcinogenicity testing (2-year bioessay} via oral exposure ----------------- ------- --- 21D Exposure levels in humans living near hazardous waste sites and other populations, such V DEHP...... ...... as exposed workers. 22A Epidemiotogieal etudes on the beam effects of DEHP (Special emphasis endpoints in clude: cancer). 22B Dose-response data in animate tor acute- and tatermediata-teaatton oral exposures. The subchronic study should inducts an extended htetopattiotogical evaluation of the immunologic and neurototpc systems. 22C MUftfgsnerstton reproductive toxidty study via oral exposure---------------....----------- -------- 22D Comparative toxtooUnetto studes (Studtes designed to examine how primates metabolize and distribute DEHP as conparad to rodents via oraT exposure). 22E Exposure tovete in humans lying near hazardous waste sites and other populations, such as exposed worker*. 22f Potendte candktate torsubregbtry of exposed persons ._____ ---- ................................ Selenium 23A Doss response data in animate tor. acute-duration oral exposure-------.-------------------------- 23B Immunotoxicotogy battery of teste vis oral exposure ___--..-------- --------------------------- 23C Epidemiotogieal ttudtes on the health effects of selenium (Special emphasis endpoints In clude: cancer, reproductive and developmental toxidty, hepatotoxidty and adverse skin effects). 230 Exposure levels In humans living near hazardous waste sites and other populations, such a* wposerf workers. 23E Potential candidate tor seixegistry of exposed persona........ Chloroethane------- 24A Dose-response data In vftnate tor acute- and intermediate-duratian orat exposures. The subchronic study should include in evaluation of immune and nervous system (and be havior. demeanor) tissues, and extended repoduclive organ htetopethotogy. 248 Dose-response data in animals tec chronic inhatotioaespoeurae. The study should indude an evetuatiea ol nervous system (end behavior) betaes. 24C Potential cancldato to* edategtotty of anpoeed parsons------------------------------------------------ * * tr tr These substances are inducted in ihe poof candtoate substances tar subregistry development These substances win be considered for se 9- lection as primary contaminants by the Drvbton of I team Studies. ATSDR. during each selection process. if V Table 2.--Priority Data Needs Being Addressed by EPA rule Making >0 Priority Data Need TSCA/BFRA Mnmnry ................ ....... Vinyl Chtortde____ Benzene........ _........ ........ 3B 3C 48 4E SA ikli tefe ninalt tnr wttt mtpfWi Immunotoxicotogy battery of tests via oral exposure Mdtigenerstion reproductive toxidty study via inhalation--------- --------- --------------- 2-apadatdBMatopmntaltoudty study via inhalation--------------------------------------------Dosera^xmae data la animate to* intermedtotoduratian oral exposes*. The ubchronto study should indude an extended reproductive organ histopathotogy. SC Naurotcudcdogy battery of testa via oral exposure . ... -. .-- Trichloroethytene 10A - Dose reeponse date In animate to* acute duration oral snpasrae -------------------------- toe imnrunotoidedogy battery of tests via the oral route____ .. --------------------- Chromium____ ...---------- 12A Dose-rosponse dote In animate tor acutoduratioe expoeura to ehromium(VB and (111) via oral exposure. 12B Mutogeneetloa caprocijcttve toxtoity study via oral evpnrmre to chromium (III) and (VI). 12C Tetrachloroethytone--------- 13A Immunotoxicotogy battery of tests following oral exposure to chromium (III) and ftfl).... Dona response date in animate to* acutadurabna oral exposure, including neuropathology and demeanor, and kanunpatedog*. _ 13B Mdtigeneration reproductive toxidty study vie oral exposure--------- --...---------- ... . * 13D 2-Spades developmental toxidty study vie oral exposure____________....----..... TSCA. TSCA. TSCA. TSCA. TSCA. TSCA. TSCA. TSCA. TSCA. TSCA. TSCA. TSCA (inhalation study). TSCA (inhalation study). TSCA study). CMA 113605 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 ID Cyanide...........................- ISA 158 ISC Beryllium............................ 17A 17B 17C 17E Toluene ............................ ISA 188 Methylene Chloride _____ - 20A 208 Chloroethane.................. _ 24A Priority Data Need TSCA/FIFRA Dose-response data in animals for acute- and intermediate-duration exposures via in halation. The subacute study should include extended reproa/cthe organ histopathology and evaluation of neurobehavioral and neuropathotogical endpoints. 2-Species developmental toxicity study via oral exposure --.-- ---------------- ------- Evaluation ol the environmental fate of cyanide in soil -------- ------- ---------------------- -- Dose-response data in animals for acute- and intermedate-duration inhalation expo- sures. The subchronic study should include extended reprodrciive organ histopathology. 2-species developmental toxicity study via inhalation exposure ------------ --------Environmental tate in air. factors affecting bioavaflabiHty in air.------.-----------------Immunotoxieoiogy battery of tests following oral exposure ------------------------- ----- Dose-response data In animals for Mermedtetedura&on oral exposures. The study should include an extended histopethotogica! evaluation of the immune system. Comparative toxcoklnetic etudes (Characterization of absorption, dstribution, and excretton via oral expoatse). Dose-response data In animals for intermedaie-duratton oral exposure. The study shotid include extended Immunopathology and neuropathology. 2-apedea developmental toxicity study via the oral route---------------------------------- ...... Doee-response data In animate for acute- and Werroedale-duratton oral exposures. The subchronic study should Indude an evaluation of immune and nervous system (and behavior, demeanor) tissues, and extended reproductive organ histopathoiogy. s' 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 PCBs Methylene chloride ID 7B 7E 20A 200 Priority data need Firm Epidemiological studee on the health effects of PCBs (Special em phasis encoints include: knmunotoxidty, gastrointestinal, toxfdty, tver, kidney, thyroid, toxicity, reproductive/developmental, toxicity). Dose-response data in animats tor acute- and Intermediate-duration oral exposure. The subchronic study should include extended reproductive organ hietopethotogy, neuropathology and demeanor, and Immunopathology. 2-apadas developmental toxicity study via the oral route -------- ........ General Electric Company. General Electric Company. Hatogenated Solvents Industry Alliance. Hatogenated Solvents Industry Alliance. Subetance Table 4.--Priority Data Needs Being Addressed by MHPF Institutions ID Priority data need rns- ttun,vo-io--n Lead 1A 1C Mercury____________ 3A Benzene__ ,_________ 58 PAHs...... ......... ........... 9A 9D Trichloroethylene ,,,,,, 108 Mechanistic studee on the neuotoxic effects of lead ... Florida A & M University. Texas Southern University. Exposure levels in humans living near hazardous The Ktog/Draw Medea! Center of the Charles R. waste sites and other populations, such as exposed Drew University of Medtdne and Science. worker*. Morehouse School of Medicine. Mutogeneration reproductive toxicity study via oral ex Tuskegee University. posure. 2-spades developmental toxicity study via oral expo Xavier University. sure. Dose-response data in'animals for intermedate dura Meharry Medical College. tion oral exposures. The subchronic study should in clude extended reproductive organ histopathology and immunopathology. Dosfrresponse data in animals tor acute- and inter- Meharty Medea! College. medato-duratton inhalation exposures. The subchronic study should include extended reproduc tive organ histopathoiogy and knmunopathotogy. Naurotoxicotogy battery of tests via oral exposure____ Texas Southern University. CMA 113606 Federal Register / Vol. 59, No. 47 / Thursday. March 10, 1994 / Notices 11441, Tabue 4.--Priority Data Needs Being Addressed by MHPF Institutions--Continued Substance ID Priority data need Institution Toiuont ..........*++ 23(1C ............. 1 18C 21A Neurotoxjcotogy battery ot tests via oral exposure ---. Dose-response data in animals tor acute- and inter- medfete-durabon oral exposures. The subchronic study should include an extended histopathoiogical evaluation of the immunologic and neurological sys tems. Texas Southern University. Xavier University. Tuskegee University. Table 5.--Priority Data Needs Being Addressed by the ATSDR Great Lakes Human Health Effects Research Program Substance ID Priority data need Institution Lead .............------------- 1C Mercury, 3A 3D PCBj 3E 7A 7E 7F PAHs 9E 9F DDT -------------------- 11D ME 11F 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 Wisconsin--Superior. New York'State Health Department University of Illinois at Chicago. University of Illinois at Urbane-Champaign. Wisconsin Department of Health and Soda! Services. MuMgenerstion reproductive toxicity State Unrversity of New York at Oswego. study via oral expoewa. Expostse. levels in humans living near hazardous waste sites and other populations, such as ex posed workers. University of Illinois at Chicago. State University of New York at Buffalo. State University of New York at Oewego. Michigan Stale University. University of Wisconsin-Superior. New York State Health Department University of IMnois at Chicago. University of IMnoia at Urbane-Champaign. Wisconsin Department of Health and Social Services. Potential candidate tor subregistry of Wisconsin Department of Health and Social Services. exposed persons. Dose response data in animats for University of Wisconsin--Superior. acute- and IntermecSate-duratton oral exposures. Epidemiological studtos on the health State University of New York at Buffalo. effects of PCBs (special emphasis State University of New York at Oswego. endpoints include: immunotoxidty. University of Wisconsin--Superior. gastrointestinal toxicity, liver, kid University of Illinois at Chicago. ney, thyroid toxicity, reproductive/ University of Illinois at UrbarwChampaign. developmental toxidty). 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 populabons, such as ex- Michigan State University. poeed workers. f University of Wisconsin--Superior. New York State Health Department University of Illinois at Chicago. University of Illinois at Urbana-Champeign. Wisconsin Department of Health and Social Services. Epidemiological studtos on the health Wisconsin Department of Health and Social Services. effects of PAHs (special emphasis enrtodnts include: cancer, dermal, hemdymphatip, and hepatic). Exposure levels In humans living Wisconsin Department of Health and Social Services. near hazardous waste sites and other poputabons, such as exnrmnrt wOffcArft. Epidemiological studies on the health affects of DDT. DDD and DDE (special emphasis endpoints In clude: immunotoxiclty, reproductive and developmental toxidty). State University of New York at Buffalo. State University of New York at Oswego. Michigan State University. University of IMnois at Chicago. Wisconsin Deportment of Health and Social Services. Exposure levels In humans living State University of New York at Buffalo. near hazardous waste sites and other populations, such as exposed workers. State University of New York at Oswego. Michigan State University. University of IMnois 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. 94-5555 Filed 3-9-94; 8:45 am] SLUM COOS 410-79-9 CMA 113607