Document MDpLRLzvK3ZG37py89pjZa1L

CMm CHEMICAL MANUFACTURERS ASSOCIATION April 15, 1994 Dear Vinyl Chloride Research Coordinators: The next VCRC meeting is scheduled for May 19, 1994. The agenda for the meeting is enclosed. Also enclosed are: 1) a draft scope of work for an update of the mortality among vinyl chloride workers; 2) an historical perspective on inter-industry vinyl chloride study; and, 3) the benefits of updating the inter-industry study of vinyl chloride workers. Please review these documents in conjunction with Dr. Richard Reitz's abstract on physiologically-based pharmacokinetics model for vinyl chloride and the ATSDR Federal Register notice on vinyl chloride research data needs that were sent to you with my March 30 letter. I am looking forward to seeing you on May 19. Sincerely Enclosures Hasmukh C. Shah, Ph.D. Manager, Vinyl Chloride Panel R&S150623 2501 M Street, NW, Washington, DC 20037 Telephone 202-887-1100 Fax 202-887-1237 rJ Responsible Care* A Public Commitment 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), 1/ Disease Registry [ATSDR-79] ADDRESSES: Private sector organizations interested in volunteering to conduct' this type of research may write to Dr. states that it is the sense of Congress that the costs for conducting this research program be borne by the Status of the Superfund Substance- William dbulas. Chief, Research manufacturers and processors of the Specific Applied Research Program Implementation Branch, Division of 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'* 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 Reauthorization Act (SARA) (42 U.S.C. 9604 (i)l. 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 S2176). The list Toxicology, Agency lor Toxic Substances and Disease Registry, Mai1stop E-29,1600 Clifton Rood, NEL, Atlanta, Georgia 30333. FOR FURTHER INFORMATION CONTACT. Dr. William Cibulas, Chief, Research Implementation Branch, Division of Toxicology, Agency for Toxic . Substances and Disease Registry, Mai1stop E-29,1600 Clifton Road, NE., Atlanta, Georgia 30333, telephone (404) 639-6306. SUPPLEMENTARY INFORMATION; Background The Comprehensive Environmental. Response, Compensation, and liability Act of 1980 (Superftmd) or GERCLA, as amended by the Superfund Amendments and Reautborization Act (SARA) [42 U.S.C. 9604(i)), requires that Substances Control Act (TSCA) and by registrants under the Federal Insecticide, Fungicide, and Rodentidde Act (FTFRA), 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 priorities on mechanisms for filling data needs; (2) coordinate knowledge f 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 final form on November 16,1992 (57 FR 54150). ATSDR (1) Jointly with the Environmental Protection Agency (EPA). develop and prioritize a list of hazardous substances found at National data needs; and (4) maintain a scheduled forum that provides an overall review of the ATSDR SSARP. The TASARC has met four times since The 38 substances, each of which is found on ATSDR'a "List ofPriority Hazardous Substances'*' (56 FR 52166, October 17.1991), are aldrin/dfeldrfn, arsenic, benzene, beryllium, cadmium, carbon tetrachloride, chloroethane, chloroform, chromium, cyanide, p.p'DDTJ3DEJJDD, di(2- etbylhexyl)phthalate, lead, mercury, methylene chloride, TiirVni, polychlorinated biphenyl compounds (PCBa), polycyclic aromatic Priorities list (NPL) sites. (2) prepare toxicological profiles for these substances, and (3) assure the initiation of a research program to fill Identified data needs associated with the substances. Before starting such a program, ATSDR. will consider recommendations of the Interagency Testing Committee established under section 4(e) of the Toxic Substances Control Act an the type of research that should be done. tile initiation of the SSARP. This notice provides the status of ATSDR's efforts to implement the SSARP, focussing on ongoing activities relevant to test rule development under TSCA/FIFRA, private sector voluntarism, and direct use of CERCLA funds. Additional data needs are being addressed through an interagency agreement with NTP, by ATSDR's Great Lakes human health effects research program, and other Agency programs. To date, 59 priority hydrocarbons (PAHs) (includes 15 ^ On October 17,1991, ATSDR . data needs associated with 35 ATSDR substances), selenium, announced the identification ofthe priority hazardous substances tetrachloroethylene, toluene, priority data needs for 38 priority (including 15 PAHs) an being trichloroethylene, vinyl chloride, 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 l). private sector organizations tovolunteer to conduct research to fill specific A. TSCA/FIFRA initiatives. ATSDR encourages private priority data needs. On November 16, 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 Superfund priority hazardous substances (57 FR priority data needs of mutual interest to Applied Research Committee (TASARC) 54150). Federal programs. These data needs will comprised of scientists from ATSDR, The major goals of the ATSDR SSARP be filled through a program of the National Toxicology Program (NTP), ore: (1) To fill the substance-specific toxicological testing under TSCA. This and the EnviramnentaTProtection information needs of the public and portion of the research will be Agency (EPA) will review all proposed voluntary research efforts. scientific community, and-(2) to supply information necessary to conduct conducted according to established TSCA procedures and guidelines. This DATES: ATSDR consider* the voluntary comprehensive public health 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 sites. 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 to volunteer generalized to other substances or areas the EPA under its authorities following R&S 150624 Federal Register / Vol. 59, No. 47 / Thursday. March 10. 1994 / Notices 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 Halogensted Solvents Industry Alliance priority hazardous substances, and (2) to added to its Master Testing List, the first (HSIA). To date, through the voluntary enhance 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 are under discussion, potentially The areas of research at MHPF priority data needs for oral exposure to leading to the signing of two institution* include those related to tetrachloroethylene, cyanide, and memorandums of understanding (Table broad areas of toxicology and beryllium, in response to other Federal 3). environmental health science. Some of government agency needs. ATSDR will During FY1993, ATSDR staff the MHPF member institutions are consider proposals to conduct members met with officials from GE to conducting health studies of minority inhalation studies in conjunction with discuss the Agency's research agenda groups exposed to ATSDR's priority pharmacokinetic studies for these for PCBs. The Agency has identified hazardous substances. substances in lieu of bioassays using mutual interests in environmental fate D. National Toxicology Program oral exposures. It is anticipated that *****frATrt tVtMA testing and human health endpoints assessments and has initiated ATSDR maintains an interagency stud i discussion on these studies with GE. pha (ATSDR met with HSIA ATJ ^ I representatives to discuss the use of S< ---------------- -sub Mat fall 4 ai not out Fuimenuore, 4 owi h uia bww.w.M the appropriate mechanism for testing PAHs, because the PAHs are by products of multiple Industrial processes and, therefore, it is difficult identify specific manufacturers. In addition, TSCA guidelines are not to J physiologically-based pharmacokinetic (PBPK) models to fill priority data needs for six volatile organic compounds. The Agency selected methylene chloride to start using PBPK modeling to address ATSDR's toxicity priority data needs because of the extensive database on this substance. The toxidty priority data needs for the remaining 5 volatile organic compounds (carbon tetrachloride, chloroethane, chloroform, tetrachloroethylene, end trichloroethylene) may be addressed via 1 similar voluntary efforts in the future. available for some of the ATSDR C. CERCLA-Funded Research (Minority agreement (1AG) 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 effects. Often these studies include an assessment of the substance's ability to cause cancer, reproductive toxidty, and birth defecta. Tire results of these studies are used by regulatory agendes such as the Food and Drug Administration and the EPA, various environmental and industrial groups, and ATSDR to improve the ability to conduct public health assessments at NPL sites. Under this agreement, one toxidty priority data need identified in .the SSARP (carbon tetrachloride, priority data needs such as the Health Professions Foundation Research immunotaxicology 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. $4 million cooperative agreement in September 1993 and should be chloride. Moreover, some of the ATSDR priority hazardous substances are considered more appropriate for FIFRA than TSCA. e.g., arsenic, DDT, and aldrin/dieldrin. The Office of Pollution, Prevention and Toxics (OPPT), EPA, forwarded the data needs for these substances to the Office of Pesticide Programs for evaluation. program with the Minority Health completed in February 1994. Professions Foundation (MHPF) to support substance-specific ' E. Great Lakes Human Health Effects investigations. This cooperative venture Research Program is supported by the direct use of Some of the priority data needs CEROLA funds. During FY 1993, about identified in the SSARP have been $4 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, seeds 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 substance-specific data needs identified respective studies are listed in Table 5. 4758). 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 consultation ' 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 projects are listed in Table 4. adverse effects of pollutants in the Great such as test rule development through The MHPF, a not-for-profit 501(c)(3) Lakes 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 InvenUnna miwv mnfniPV. R&S 150625 11436 Federal Register / VoL 59, No. 47 / Thursday, March 10, 1994 / Notices benzo[a]pyrene. hexachlorobenzene, priority data need for 37 of the 38 consumer products, or occupation can fujsns, 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 wititin the Agency's National PAHs) are being conducted by the resulting from exposure to these contaminants. Exposure Registry who have potentially ATSDR Great Lakes human health been exposed to these substances. effects research program (Table S). The ATSDR-supported research The list of 38 priority hazardous projects focus on these high-risk substances in the SSARP was forwarded populations to try to further define the to ATSDR's Exposure and Disease human health consequences of exposure Registry Branch (EDRB), Division of to these persistently toxic substances. Health Studies, for consideration as The research activities include, but are potential candidates for subregistries of not limited to: (1) Characterizing exposed persons, based on criteria exposure and determining the profiles described in EDRB's 1988 document, and levels of Great Lakes contaminants "Policies and Procedures for in biological tissues and fluids in high- Establishing a National Registry of risk populations; (2) identifying Persons Exposed to Hazardous sensitive and specific human Substances." To date, ATSDR has reproductive/developmental end points selected benzene, chromium, and and correlating them to exposure to Great Lakes contaminants; (3) trichloroethylene aa primary contaminants to establish subregistries determining the short- and long-term in the National Exposure Registry. riskfs) of adverse health effects in However, aldrin/dieldrin, carbon progeny whose parents were exposed to Great Lakes contaminants; (4) investigating the feasibility of tetrachloride, chioroethane, chloroform, cyanide, p,p'-DDY, DDE. DDD. di (2ethylhexyl) phthalate, mercury, establishing registries and surveillance methylene chloride, PAHs, selenium, cohorts in die 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 offsets 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 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 aa more information on 30,1992, ATSDR announced nine the chemicals and exposure sites awards under this program. . become available. In FY 1993, about S3 million was With regard to epidemiologic studies, allocated to support the continuation of ATSDR believes that for many of the 38 the research projects conducted at the nine institutions originally funded during FY 1992. In addition, ATSDR awarded one new grant to the Michigan Department of Public Health to design, establish, and operate a professionally creditable interlaboratory quality priority hazardous substances, an extensive amount of 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 assurance/quality control program for comments, the Agency's SSARP will the ATSDR Great Lakes human health effects research program. address substance-specific rather than site-specific epidemioiogicstudies. F. Other ATSDR Programs The substance-specific studies are designed to determine substance- In its role as a public health agency specific cause and effect, hr this case, addressing environmental health, ATSDR is not necessarily directed ATSDR may, where appropriate, collect toward populations exposed via the 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 Medical 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 ATSDRsponsored auspices. Toward that end, ti^r 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 byATSDR. 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 vis the SSARP will be used for public health assessments and to reassess ATSDR's substance-specific priority data needs. The Agenq? 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. WaharR.Dewtfla', 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 andDisease Registry. r&S150626 Federal Register / Vol. 59, No. 47 / Thursday, March 10, 1994 / Notices 11437 .-- ATSDR'Table i Substance-Specific Priority Data needs Currently Being addressed Under s applied Research Programs Substance ID Lead------------ -- -- IB 1C / Arsenic 2A 2B 2C 2D Mercury -- 3A 38 3C 3f> y Vinyl Chloride 3E ___ 4A 4B 4C 4D 4E 4F / Benzene 4G ___ 5A 58 SC 5D 5E Cadmium__ ----- 6A 68 v' PCBs.......... ___ 7A 78 7C 7D Chloroform ............ 7E 8A 88 PAHs__________ 8C 80 9A 98 9C 90 Trichloroethylene ,, 9E 9F 9G 10A tOB IOC 100 Priority Data Need Addressed Mechanistic studies on the neurotoxic effects of lead Analytical methods lor tissue levels ..................... --................. .--............------ Exposure levels in humans fixing near hazardous waste sites and other populations, such as exposed workers. Comparative toxicoicinetic studies to determine 3 an appropriate animal species can be identified. Haif-tives in surface water, groundwater ,--... ........ -................----------- Bioavailabifity from soil___ _ ___________________ __________________. Exposure levels in humans living near hazardous waste sites and other populations, such as exposed workers. Multiganecaten reproductive toxicity study via oral exposure -----.....-....... -- -- Dose-response data in animals for chronic-dieaiian oral exposure--------------------------------- . Immunotoxicotogy battery of tests via oral exposure--------------------------------------------------- Exposure levels in humans Irving near hazardous waste sites and other populations, such as exposed workers. Potential cancfidate tor subregistry of exposed persona--------------- --------------------- .---------- Doee-response data in animals for acute-duration inhalation exposure------,-------- ------ Multigeneration reproductive toxicity study via inhalation ------------ .-- Dose-response data in animals tar chronic-duration inhelation exposure........ --................ . Mitigation of vinyl chloride-induced toxkity , ( .... ...............--................ . 2-species developmental toxicity study via tohetation.......................................... . Exposure levels to humans fivtog neer hazardous waste site# and other poptdations, such as exposed workers. Potential candidate for subregistry of exposed persons--.-------------------------------------- -- Dose-response data in animais for acuta- and intermediate-duration oral exposure. The subchronfo study shoUtt Incfoda an extended raprodktcttve organ histopathoiogy. 2-spedes developmental toxicity study via oral exposure -- ---- --- ------------ Neurotoxfootogy battery of tests via oral exposure , ...... ...... --.... ....... ....... Epidemiological studies on the health effects of benzene (Speciaf emphasis endpoints in- - duder irTXTXjrxXOwatyl Exposure terete fit humane living near hazardous waste sites and other populations, such as exposed workers; Analytical methods for biotogfcaf tiseues and IMdS and environmental metia____________ Exposure levels in humans IMng near hazardous waate sites and other populations, such as exposed workers; Dose-response data in animate tor acute-and Intermediate duration oral exposures Biodegradation of PCBS in water; bioavailability of PCBs in air, water and soil ---------- .... Dose-response data to animais for acute- and totormedtatedUretton inhalation exposures. The subchronic study should Include extended reproductive organ Nstopathotogy. Epiderriotogicai etudes on the health effects of PCBs (Special emphasis endpoints include: Immunotoxidty, gastrointestinal toxicity1, liver, kidney, thyroid toxicity, reproductireidevel- opmentei toxicity). Exposure tovete in humans IMng near hazardous waste sites and other populations, such as exposed workers. Dose response data in animate tor totermedteto-duration oral exposure --....-----.------ EpidemioAvcaf studies on the haallfr effects of chloroform (Specter emphasis endpoints to- etude; cancer, neurotoxicity, reproductive and developmental toxicity, hepatntoxidty, and renai looocnyp. Exposure levels irr humans living near hazardous waste sites and other populations, such as exposed worftera; Potential canddaW for subregtetry of exposed persons______ ,,._____ ____ _____--------- Dose-response data ki animats for Intermediate duration oral exposures. The subchronic study shodd include extended reproductive organ histopathotogy and immunopaSioiogy. ; 2-spedes dsvetopmentat toxicity study via Halation or orW exposure------ -------------- .-- Mechanistic studies on PAHs, on hoar mixtures of PAHs can influence the ultimate activa tion of PAHs, and on how PAHs affect rapidly proliferating tissues. Doee-response data in animais for acute- and intermedlata-duratian inhalation exposures. The .subchronic study should Include extended reproductive or&o histopathotogy and nsnunopathotogy. Epktemiotogicat studies on the health effects of PAHs (Special emphasis endpoints include; cancer, dermaf, hemofymphatic, and hepatic). Exposure levels in humans living near hazardous waste sites and other populations, such as exposed workers. , Potential candidate tor subcegistry of exposed persons_________ _______ _________--...... | Dose-response data in animate for acute-duration oraf exposure ________ ________ --- Neurotoxicology battery of tests via the oraf route __________ ________ _--------------------- immunotoxicotogy battery of tests via tip oraf route_______ ___________________ _----- Epidemiological studies on the health effects of trichloroethylene (Special emphasis endpoints include: cancer, hepatotoxfcity, renal toxicity, developmental toxicity, and neurotoxicity). * *r * * R&S 150627 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 Programs--Continued Substance ID Priority Data Need Addressed DDT v' Chromium Tetrachloroethyiene AMrin/DiekJrin___ Cyanide 10E 11A 11B 11C 11D 11E 11F 12A 12B 12C 12D 12E 13A 13B 13C 13D 13E 13F 14A 14B 14C 14D 15A Carbon Tetrachloride Beryllium Toluene 15B 15C 15D 15E 16A 168 16C 16D 16E 17A 17B 17C 17D 17E 17F 18A Nickel 18B 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 toxicckinetic study (across routes/species) --............................. ------- BioavailabiSty and bioaccumulation from soi .... _____________________ --------------------- - Epidemiological studies on the health effects of DDT, DDD 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 candkfate for subregistry of exposed persons........................................... ............... Dose-response data in animals for acute-duration exposure to chromium (VI) and (III) via oral exposure and for Intermedate-duration exposure to chromium (VI) via Orel exposure. Multigeneratton reproductive toxicity study via oral exposure to chromium (ill) and (VI)------ Immunotoxicofogy 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 lor acute-duration oral exposure, including neuropathology and demeanor, and immunopathology. Muitigeneration reproductive toxicity study via oral exposure------------------------------------------ Dose-response data in animals for chronic-duration oral exposure, including neuropathology and demeanor, and immunopathology. 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 subregistry of exposed persons______ ____ ----------- --------------- 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 subregistry of exposed persons ...___ 1_____ .....------ ------- ---....... Dose-response data in animals tor acute- and kitermorfate-duration exposures via inhala tion. The subchronic study should include extended reproductive organ bistopathology and evaluation of neurabehavtorai and neuropathologica! endpoints. 2-species 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 candkfate lor subregistry of exposed persons _________________ ____ ________ _ Dose-response data in animals for chronic oral exposure. The study should include ex tended. reproductive organ and nervous tissue (and demeanor) histopathology. Immunotoxicotogy battery of tests via oral exposure Halt-life in soil --.--. Exposure levels in humans living near hazardous waste sites and other populations, such as exposed workers. Potential candkfate for subregist/y of exposed persons...... ............................. .................. .-- Dose-response data.in animals tor acute- and intermedtote-duratton inhalation exposures. 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______________ ___ _______ Analytical methods to determine environmental spectabon ____ ___________ ___ _-- Immunotoxicotogy battery of tests following oral exposure ____________~____________ ____ Exposure levels in humans Irving near hazardous waste sites and other populations, such as exposed workers. Dose-response data in animals for acute- and Intermediate-duration oral exposures. The subchronic study should include an extended histopathological evaluation of the immune system. Comparative toxicokinetic studfes (Characterization of absorption, , distribution, and excre tion via oral exposure). Neurotoxicotogy battery of tests via oral exposure _______ ____ ______________ --~--------Mechanism of tohjene-induced neurotoxicity ________________________ _______ ------------- Exposure levels in 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-species developmental toxicity study via the oral route-_______________________ Dose-response data in animals for acute- and intermediate-duration oral exposures .-- Neurotoxicotogy battery of tests via oral exposure........... ......... ............................ ......... ....-- Bioavailability of nickel from sofl____________ ____ ;___ ___________ ______ ___________ -- Exposure levels in humans living near hazardous waste sites and other populations, such as exposed workers. * * * * 33 C/3 oOCSJl rcoo Federal Register / Vol. 59. No. 47 1 Thursday. March 10. 1994 / Notices Table i.--Substance-Specific priority data Needs Currently Being addressed Under ATSDR's applied Research Programs--Continued Substance Methylene Chloride ID 2QA D<IteSS"S Priority QaU Need oral ujoraino j Addresseu 20B 20C 20D Zinc .............................. 21A V DEHP __ 21B 2TC 21D 22A E^^TM S'PT'*3'toxicrty ^ ** ^ ^ fWAe................................. ................j as p^ed <'V'ns near hazan*MS waste sites and other populations, such i Arten^canttidaia tor subregistry ot exposed persom ................................................... *"*** ** acute" a**1 intermediate-duration oral exposures. The s~y should include an extended htsiopathokxpcal evaluation ot the) 81X1 Murc*OQiGal systems. ^9taon reproductive tcudcity study via oral exposure________________________ TM^oge^r testlno (2^ear bioassayl via oral expoaw___________ tJ^**teteveb inhumans King near hazardous waste sites and other populations, such j E,SasSexap^osSed^Lwo*r,kUe^rsia. , ^ *** bea"h 6fleas 01 DEHP (Speaai emphasis endpoints in- j 22B ^?e^?>0r3e_ in^aTMma*4 ** acute- and iotermediate-duration oral exposures. The I S!Ut7 sho?k* an extended hbtopathotogical evaluation of the inwunologic and neurologic systems. 22C ffffMegfa" npmcfcctNe toxic*y study via oral expostre___ ____________ _ 22D `-'Cnparaove toxicotonetlc studes (StucSes designed to examine how primates metabolize I ITL?P" howyeted to rodents via oral exposure), 22E cxposww Wvys to humans King near hazardous waste sites and other populations, such I as expose*? wonws. I Selenium-.................. 22F 23A 238 23C Potential carctidate torstixegfstry of exposed persons _____ JAMe-response data in animals for.acute-duration oral exposure Immunotoxicoiogy battery ot tests via oral exposure Epidemiological studies on the health effects of selenium (Special emphasis endpoints in clude: cancer, reproductive and developmental toxicity, hepatotoxidty and adverse skin effects). 23D Exposurn levels in humans living near hazardous waste sites and other populations, such J as exposed woriter*. 23E Potential candidate for sitoregistry of exposed persona.. *r Chloroethane 24A Dose-response data in animals tor acute- and intermediate-duration oral exposures. The I sttochronto study should include an evaluation of immune and nervous system (and be-1 havior. demeanor) tissues, and extended reproductive organ hrstopathology. 24S Dose-tesponsa data in animals tot chronic inhalation exposures. The study should include ] an evaluation of nervous system (and behavior) tissues. .i___________2_4_C_______P_o_t_e_n_ti_a_l c_a_n_d_k_t_e_ia_t_o_r_s_u_fa_r_o_g_to_a_y__o_f _e_x_p_o_s_e_d_p_e_r_s_o_n_s_________________________________________i----------------- * These substances are incfUJed in the poof of candidate substances tor subregistry development. These substances will be considered for se lection as primary contaminants by the Pension of Health Studies, ATSDR during each selection process. 2.-- EPATable Priority Data Needs being Addressed by Rule Making ID Mercury ------------------------ [3B 3C Vinyl Chloride......... 48 4E Benzene............. .............. SA Trichloroethylene _ Chromium......................... SC 10A 10C 12A . 12B 12C Tetrachloroethytene........ _ 13A 138 * 13D Priority Data Need Doae-response da* mammals tor chrontodufation oral exposure Immunotoxicoiogy battery of tests via oral exposure ____ Multigeneration reproductive toxicity study via inhalation-___________________ ______ 2-species cfeveiopcnental toxicity study via inhalation________ ____ _. .. ........ Dose-response data in animals foe inteKnediaie-duratiocr oral expostro. The subcrironic study should include an extended reproductive organ hntopathoiogy. Neurotoxfcatogy battery of testa via oral exposure . --____ Immunotoxicoiogy battery of tests via the oral route------ ....________ _ Dose-response data in antimis for acute-duration exposure to ehromium(Vt) and (111) via Oral exposure. Muttigeneration. teproductne toxicity study via oral exposure to chromium (lit) and (VI). Immunotoxicoiogy battery of tests following oral exposure to chromium (III) and 0/1) Dose-response data to animals tot acute-duration oral exposure, including neuropathology and demeanor, and imraunopetriolofly. Muttigeneration reproductive toxicity study via oral exposure _ ........ ......................... 2-Species developmental toxicity studv via oral exposure . ._ ........................ TSCA/HfRA TSCA. TSCA. TSCA. TSCA. TSCA. TSCA. TSCA. TSCA. TSCA. TSCA. TSCA. TSCA finhalation study). TSCA Onhalation study). TSCA (inhalation study). R&S150629 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 15C Beryllium............................ 17A 17B 17C 17E Toluene ............................. 18A 188 Methylene Chloride 20A 206 Chioroethane................... ,, 24A Priority Data Need TSCA/FIFRA Dose-response data in animate for acute- and intermediate-duration exposures via in halation, The sifcacute study should include extended reproductive organ histopathotogy and evaluation of neurobehavtorai and neuropathotogical endpoints. 2-Species developmental toxicity study via oral exposure-------------------- ----- Evaluation of the environmental fate of cyanide in soil ------ ----------- --------------------Dose-response data in animate for acute- and intermedate-djration inhalation expo sures. The siPchrontc study shorid include extended reproductive organ histopathotogy. 2-species developmental toxicity study via inhalation exposure-------------------------------Environmental fate in air. factors affecting bioavailability in air___________ _ Immunotoxicology battery of tests following oral exposure -------------------------------------- Dose-response data in animate for Mermedateduration oral exposures. The study should include an extended histopathofogical evaluation of the immune system. Comparative toxicotonetic studes (Characterization ol absorption, dtetribution, and ex cretion via oral exposure). Dose-response data in animate for intermedate-duration oral exposure. The study should include extended immunopathotogy and neuropathology. 2-species devetopmentaktoxidty study via the orai route------------- ----------------- ---,, Dose-response data, in animate for acute- and intermedfate-duration oral exposures. The subchronic study should include an evaluation of immune and nervous system (and behavior, demeanor) tissues, and extended reproductive organ histopathotogy. \ TSCA. TSCA (inhalation study). TSCA. TSCA. TSCA. TSCA. TSCA (inhalation study). TSCA. TSCA. TSCA. TSCA. TSCA. (EPA will Only address th immune system requirement of this Priority Data Need) Table 3.--Priority Data Needs potentially Being addressed by Voluntary Research Substance 'O PCBs.............. ............ . 78 7E Methylene chloride______ 20A 208 Priority data need Firm BVyingradation of PCBt in wtev...........-...... -......... ...... Epioemtotogical studes on the health effects of PCBs (Special em phasis endpoints include: immunotoxicity, gastrointestinal, toxicity, liver, Kidney, thyroid, toxicity, reproductive/developmental, toxicity). Dose-response data in animate for acute- and Intermedate-duration oral exposure. The subchronic study should indude extended re productive organ htetopathoiogy, neuropathology and demeanor, and immunopathotogy. 2-species developmental toxicity study via the oral route.................. General Electric Company. General Electric Company. Haiogenated Solvents Industry Alliance. Haiogenated Solvents Industry Alliance. Table 4.--Priority Data Needs Being addressed by MHPF Institutions Substance ID Lead------------------------ 1A 1C Mercury .... 3A Benzene...___________ 5B PAHs 9A 9D Trichloroethylene 108 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. , Florida A & M University, Texas Southern University. The King/Draw Medea) Center of the Charles r. Drew University ol Medtoine and Science. Morehouse School of Medicine. Multigeneration reproductive toxicity study via oral ex Tuskegee University. posure. 2-species developmental toxicity study via oral expo Xavier University. sure. Dose-response data in animate for intermedate dura- Meharry Medical College. tion oral exposures. The subchrontc study should in clude extended reproductive organ htetopathoiogy and Immunopathotogy. Dose-response data in animate for acute- and inter- Mehariy Medical College. medate-duration inhalation exposures. The subchronic study should include extended reproduc tive organ histopathotogy and immunopathotogy. Neurotoxicotogy battery of tests via oral exposure........ Texas Southern University. COOO o 's is s y Federal Register / Vol. 59, No, 47 / Thursday. March 10, 1994 / Notices 11441. Table 4.--priority Data needs Being addressed by MHPF Institutions--Continued Substance Toluene ...... Zinc____________ J ID 18C 21A Priority data need Institution Neurotoxjcotogy battery of testa via oral exposure.....-- Dose-response data in animats for acute- and inter- mediate-durabon oral exposures. The subchronic study should include an extended hrstopathologtca] evaluation ot the imnwiofogic and neuroiogicaJ 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 Stistance ID Pnonty data need Institution Lead _. ________ ___ 1C Exposure levels In txxnans 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 Urbana-Champaiga Wisconsin Department of Health and Social Services. Mercury ..................... 3A Mutbgenerabon reproductive toxicity State University of New York at Oswego. study via oral exposure. University of Illinois at Chicago. 30 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 popUaiions, 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 Urbana-Champaign. Wisconsin Department of Health and Social Services. 3E Potential canddate for subregistry of Wisconsin Department of Health and Social Services. exposed persona. > PCBs. - 7A Dose-response date In animals for University of Wisconsin--Superior. actee- and intermedate-duratlon oral exposures. 7E Epidemiological studies on the health State University of New York at Buffalo. effects of PCBs (special emphasis State University of New York at Oswego. endpoints include: immunotoxicjty. University of Wisconsin--Superior. gastrointestinal toxicity, liver, kid University of Minors at Chicago. ney, thyroid toxicity, reproductive/ University of Illinois at Urbana-Champaign. developmental toxicity). 7F 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--S<4>erfor. New York State Health Department University of Illinois at Chicago. University of Illinois at Urbana-Champaign. Wisconsin Department of Health and Social Services. PAHs_______________ 9E Epiderraologtcal studies on the health Wisconsin Department of Health and Social Services. effects of PAHs (special enphasis endpoints include: cancer, dermal, hemolymphatip, and hepatic). 9F Exposure levels in humans living Wisconsin Department of Health and Social Services. near hazardous waste sites and other populations, such as ex posed workers. DDT________________ 11D Epidemiological studies on the health State University of New York at Buffalo, effects of DOT, DOD and DDE State University of New York at Oswego. (special emphasis endpoints In Michigan State University. clude: immunotoxJtity, reproductive University of Illinois at Chicago. and developmental toxicity). Wisconsin Department of Health and Social Services. TIE 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. T IF Potential candidate for subregistry ot Wisconsin Department of Health and Social Services. exposed persons. [FR Doc. 94-5555 Filed 3-9-94; 8:45 ami MUJNO 0008410-40-* R&S 150631