Document NeJ0dK40b720emD8nd25LK0Yw

CMm CHEMICAL MANUFACTURERS ASSOCIATION March 30, 1994 Dear Vinyl Chloride Research Coordinators: A calendar to determine your availability to attend the next VCRC meeting is enclosed. A tentative agenda for the meeting also is enclosed. Dr. Greg Bond anticipates sending me the draft scope of work for the epidemiology study by*^gpJ00 I will send you the draft as soon as I receive it. Two activities recently have been initiated by EPA and ATSDR. Dr. James Knaak informs me that EPA has commissioned Clemment Associates to undertake a risk assessment for vinyl chloride. Dr. Richard Reitz, formerly of Dow Chemical, has developed a physiologically-based pharmacokinetic model for predicting cancer risk from vinyl chloride exposure. An abstract of his model is enclosed. Dr. Knaak has expressed an interest in inviting Dr. Reitz to discuss his model with the VCRC at its next meeting. As EPA's risk assessment activities for vinyl chloride already are underway, I think we should meet with Dr. Reitz as soon as possible and develop a strategy to work with EPA from the beginning to ensure a scientifically sound risk assessment. On March 10, the ATSDR announced various research activities that are underway or are planned for vinyl chloride and other chemicals. The enclosed Federal Register notice describes those research activities. The ATSDR has three different options to develop research data as described in the background section of the Federal Register notice. The VCRC commissioned Can-Tox to review the ATSDR profile for vinyl chloride last year and a final report from Can-Tox was issued early this year.- ~ This report has not been submitted to ATSDR. I will contact Dr. William Cibulas of ATSDR to discuss various research programs underway or planned as described in Tables 1 and 2 of the Federal Register notice. It is important for the vinyl chloride industry to meet with ATSDR and/or EPA to discuss the ATSDR data needs because the ultimate cost of the ATSDR data needs on the industry will be well over $500,000, if th data needs are not minimized. One way or the other, industry ultimately will have to pay for all test costs. We will discuss the enclosed Federal Register notice at our next meeting and decide on a course of action. Please complete your meeting availability calendar and send it to me by fax at 202/887-1237. If you have any questions, please call me at (202) 887-1192. Sincerely, R&S 150632 Hasmukh C. Shah, Ph.D. Manager, Vinyl Chloride Panel Enclosures 2501 M Street, NW, Washington, DC 20037 Telephone 202-887-1100 Fax 202-887-1237 Responsible Care A Public Commitment 11434 Federal Register / Vol. 59. No. 47 / Thursday, March 10, 1994 l 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 Ka^. 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), Disease Registry ADDRESSES: Private sector organizations states that it is the sense of Congress [ATSOR-TB] interested in volunteering to conduct' this type of research may writs to Dr. that the costs for conducting this research program be borne fay the Status of the Superfund Substance* William Qbulaa. Chief. Research manufacturers and processors of the Specific Applied Research Program Implementation Branch, Divisits of hazardous substances under the Toxic AGENCY: Agency far Toxic Substance* 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 fay the Comprehensive Environmental Response, Compensation, and liability Act (CERCLA), as amended by the Superfund Amendments and Reautharizatlan Act (SARA) (42 U.S.C. Toxicology, Agency for Toxic' Substances andDisease Registry, M&ilstop E-29,1600 Clifton Road. NE^ Atlanta. Georgia 30333. FOR FURTHER INFORMATION CONTACT. Dl. William Qbulaa, Chief. Research Implementation Branch. Division of Toxicology, Agency for Taxie Substances and Disease Registry. Mailstop E-29.1600 Oificn Road. NE.. Atlanta, Georgia 30333, telephone (404) 639-6306. SUPPLEMENTARY MFORMATtONT Background The Comprehensive Environmental. Substances Control Act (TSCA) and by registrants under the Federal Insecticide. Fungicide, and Rodentidde Act (FIFRA). 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 ria regulatory mechanisms (TSCA/F1FRA), private actor voluntarism, and the direct use of CERCLA funds. A Tri-Agency Superfand Applied RoaeaichCommittee (TASARQ comprised of scientists from ATSDR. NTP, and the EPA has been set up to: (1) Advise on the assignment of priorities on mechanisms far filling data 9604 (i)l, was initiated on October 17, Response, Compensation, and Liability needs; (2) coordinate knowledge of 1991. At that time, a list of priority data Act of 1980 (Superfand) or CXRCLA, as research activities to avoid duplication needs for 36 priority hazardous substances was announced in the amended by the Superfund Amendments and ReeuthorizationAct of reseerdi in other programs end under other authorities; (3) advise on issues of Federal Register (56 FR 52178). The list (SARA) (42 U.S.C. 9604(1)]. requires that science related to substance-specific was subsequently revised based on ATSDR (1) faintly with the data needs: end (4) maintain a public comments, and published in Environmental Protection Agency scheduled forum that provides an final form on November 16.1992 (57 FR (EPA). develop end prioritize a nst of overall review of the ATSDR SSARP. 54150). The 36 substances, each ofwhich is found an ATSDR*s "List ofPriority Hazardous Substances*1 (56 FR 52166,. hazardous substances found at National Priorities List (NPL) sites, (2) prepare toxicological profiles far these substances. TM (8) assure the initiation The TASARC has met four times since the initiation of the SSARP. This notice Ervides the status of ATSOR's efforts to piement the SSARP. focussing on October 17,1991), are iddrin/dieldrin, of a research program to fill identified - ongoing activities relevant to test rule arsenic, benzene, beryllium, cadmium, data nsnris ensnriafrri with the development under TSGA/FIFRA, carbon tetrachloride, chknoethana, whstwncm. Before starting soefa e private sector voluntarism, and direct chloroform, chromium, cyanide, p,p'- program, ATSDRwill consider use of CERCLA funds. Additional data DDTDDEJDDD, di(2- recommendations ofthe Interagency needs are being addressed through an ethylhexyl)phthalata, lead, mercury, Testing Committee established under - Interagency agreement with NTP, by methylene chloride, nickel, section 4(e) of the Toxic Substances ATSDR's Great Lakes human health polychlorinated biphenylcompounds Control Act on the type of reseerdi 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, announced the Identification ofthe priority hazardous substances tetrachlaroethylene, toluene, priority data needs for 38 priority - (including 15 PAHs) are being trichloroethylene, virryfehfaride, and hazardous substances (56 FR52178). addressed via theae mechanisms (Table zinc. This notice also serves as a continuous call far voluntary research requested publiccomment!,and isrited 1). private sector organizations tovolunteer to conduct reseerdi to fill specific A. TSCA/FIFRA initiatives. ATSDR encourages private priority data needs. On November Ifc ' 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 Supertund priority hazardous substances (57 FR priority data needs of mutual interest to Applied Research Committee (TASAHC) 54150). Federal programs. These data needs will comprised of scientists from ATSDR. The major goela of the ATSDR SSARP be filled through a program of the National Toxicology Program (NTF), 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 scientific community, and(2)to supply conducted according to established voluntary research efforts. Information necessary to conduct TSCA procedures and guidelines. This DATES: ATSDR considers the voluntary comprehensive public health - testing will fulfill mote than one Fedeta research effort to be important to the assessments of populations tiring near program's need. During FY1993, a continuing development of the SSARP. hazardous wests sitss. This program subset of the 117 priority data needs for Therefore, the Agmcy encourages also will provide data that can be 38 substances (shout 60) was referred to private sector organizations to volunteer generalized to other substances or areas the EPA under its authorities following R&S 150633 Federal Register / VoL 59, No. 47 / Thursday, March 10, 1994 / Notices 11435 review and endorsement by the TASARC oversight committee. Currently, 26 priority data needs associated with 11ATSDR substances have been recommended by CPA to be added to its Master TestingList, 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'* priority hazardous substances will not be added to EPA'a Master Testing list because they do not fall within the bounds ofTSCA, 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 fortesting PAHs, because the PAHs tie by products of multiple industrial processes and. therefore, it is difficult to identify specific manufacturers. In addition, TSCA guidelines are not available for some of the ATSDR priority data needs such as the development of analytical methods for cadmium and beryllium, mechanistic studies on the neurotoxic effects of lead, and the mitigation of toxicity ofvinyl 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 ofPesticide Programs for evaluation. B. Private Sector Voluntarism As part of the SSARP, ATSDR initially announced a set of proposed , procedures for conducting voluntary research on February 7,1992 (58 FR 14758). It was revised based on public comments and published on November 16,1992 (57 FR 54160). This voluntary z 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:(l) To initiate research to fill Electric Company (GE) and the ATSDR-identified data needs for Halogensted Solvents Industry Alliance priority hazardous substances, and (2) to (HS1A). To data, through the voluntary anheire* existing disciplinary capacities research efforts of GE and HSIA. four to conduct research in environmental priority data needs for two substances are under discussion, potentially health at MIFF member institutions. The areas of research at MHPF leading to the E"inE of two institutions include those related to nnnnnrnilnTn of imriiifntiii<lii^ (Table broad areas of toxicology and environmental health science. Some of During FT 1993, ATSDR staff the MHPF member institutions are members met with officials from (X to conducting health studies of minority discuss the Agency's research agenda groups exposed to ATSDR's priority for PCBs. The Agency baa 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 HSXA D. National Toxicology Program ATSDR maintains an interagency agreement (1AG) with NTT* to conduct toxicological testing of substances representatives to discuss the use of identified at NFL sites. The studies physiologically-beaad pharmacokinetic determine levels ofexposure that (PBPK) models to fill priority data needs present a significant rid; to humans of for six volatile organic compounds. The acute, subacute, and chronic health Agency selected methylene chloride to often these studies include an sta rt using PBPK modeling to address assessment of the substance's ability to ATSDR's toxicity priority date needs cause cancer, reproductive toxicity, and because of the extensive database on birth defects. The results of these this substance. The toxicity priority date studies an used by regulatory agendas needs far the remaining 5 volatile such as the Food and Drug organic compounds (carbon Administration and the EPA, various tetrachloride, chloroirthahe, chloroform, environments! and industrial groups, tetrachloroethylene, and snd ATSDR to improve the ability to . trichloroethylene) may be addressed via p'M*1* h*shh ti^f similar voluntary efforts in the future. NPL sites. Under this agreement, one C. CERCLA-Funded Research (Minority Health Professions Foundation Research Program) toxidty priority data need identified in .the SSARP (carbon tetrachloride, imntunotoxicology battery of tests via oral exposure) is currently being During FY1992, ATSDR announced a addressed. This NTP study was begun $4 million cooperative agreement rwith tea Minority Health i Foundation (MHPF) to support substance-specific investigations. This cooperative venture in September 1993 and should be completed in February 1994. . Great Lakes Human Health Effects Research Program is supported bythe direct use of Some of the priority data needs GERCLA fund*. 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 Greet Lakes ware initiated. Currently, 9 priority data human health effects research program, needs for 21 priority hazardous a separata research program. To date.12 substances (including 15 PAHs) in the priority data needs lor 19 priority SSARP are being addressed by the hazardous substances (including 15 MHPF institutions through PAHs) identified in the SSARP are being program. Also, the MHPF research addressed through this program. The program will address 13 other institutions receiving awards and their substance-specific data needa identified respective studies are listed in Table 5. in the ATSDR toxicological profiles The Greet Lakes Critical Programs Act concerning exposures and related health of 1990 mandates EPA, in consultation efforts. The Institutions receiving with ATSDR, to prepare a report by awards and their respective research September 30,1994, that assesses the projects are listed in Table 4. adverse effects of pollutants in the Great The MHPF. e not-for-profit 501(c)(3) Lakes system on the health of organization, is comprised of 11 individuals in the Great Lakea states. A minority health professions schools. Its variety of persistent toxic substances are primary mission is to research the prevalent in tha'Great Lakea, including persistent health problems that PCBs, DOT and its metabolites, dfeldrin, disproportionately plague poor and toxaphene, minx, mercury. R&S150634 11436 Federal Register / VoL 59. No. 47 / Thursday. March 10. 1994 / Notices benzofclpyrsne, hexachlarobeazene, furans, dioxins. and lead. Certain populations--Native Americans, sport anglers, fetuses and nursing infants of mothers who consume contaminated Great 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 Eopnlatlona to tty to further define the uman 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 highrisk populations; (2) identifying sensitive and specific human reproductive/develqpmental end paints and correlating them to exposure to Great Lakes contaminants; (3) determining the short- and long-term riskfs) of advene health affects in progeny whose parents were exposed to Great Lakes contaminants: (4t 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, end 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 awIanrFdsYu1n9d9e3r, tahbisonurtosRfrmamili.ian 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 Department of Public 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. Other ATSDR Program* hr its role as a public health agency aAtr--tr^, he*mi, ATSDR may, where appropriate, collect human data to validate sobstancespedfic exposure and taxidty findings; information on levels of contaminants in humans has been Identified as a priority data need far 37 of the 38 priority substances (Table 1). ATSDR will obtain this inhumation through exposure and health effects studies, and through establishing and using substance-specific 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 suhreglstries of exposed persons, based an 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 elected benzene, chromium, and trichloroethylene as primary contaminants to establish subregistries in the National Exposure Registry. However, aldrin/dialdrin, carbon tetrachloride, chlaroethane. chloroform, cyanide, p,p'-DBT, DDE.DDD, di (2ethylhexyl) nhthalate, mercury, methylene chloride, PAHa, selenium, tetrachloroethylane, and vinyl chloride remain aa a part of the candidate pooL They will be considered for selection as pjrwiy HintMitniBh Airing rii 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 mare 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 on 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, aa 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 aa DDT, PCBs, and PAHs) are being conducted by the ATSDR (heat 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 Medical Center of the Charles R. Drew University ofMedfdne and Science via the ATSDR~-MHPF cooperative agreement ATSDR expects that otheraubstance-apedfic epidemiologic studies, identified as data needs or priority data needs in the SSARP, may potentially be conducted by other Divisions witltin 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, thg 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 hear identified aa 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 fin 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. Dated-March 3,1994. Walter LDewdkv DeputyAdministrator. AgencyforTa Substance*andDiteowe Bcgtetry. Federal Register / Vol. 59. No. 47 / Thursday, March 10. 1994 / N tices 11437 table 1.-^-Substance-Specific Priority Data needs Currently being Addressed Under ATSDFTs Applied Research programs Substance Lead y Arsenic Mercury y Vinyl Chloride to 1A IB 1C 2A Priority Data Need Mecharisbc ttudaa on the neurotndc effects of lead Analytical methods for tissue levels Exposue levels in humans fcring near hazardous waste sites and other populations, such as exposed workers. Compendive taricoldnabc states to determine K an appropriate animal spades can be identified. Half-fives in tuface water, flroundeater ----- ------------ . ... .............................. Bioavaiiabiity (rom soil Exposure levels in humans fiving near hazardous waste sites and other populations, such exposed workers. MUKgsnscabon reproductive toxidty study via oral exposure_____ Dote nwponee data In enimais tor dvorvo-tkastion orei exposure Immunotoxicotogy battery ol tests we oral exposure , Exposure levels In humans fiving wear hazardous wasta skat and other pcpdabons. such canddate ter stixegistry of exposed persona in enimais tor acute-duration irhaialion exposure , Mutogenersbon reproductive toxicity study vie Wtatafion Onte-msprfee data in enimalettrrfhrrmfiv4ifnlwTT>ntmhff?ne>^n"|ir|* Mibgabon ol vinyl dScrfcie+xJueedtoxidty z-epedss oevetopmerset nxicxy suty vei wristsnon. ErqMswe leved In humane INing near hazardous i i abas and other populations, such Addressed V A "7 Benzene Cadmium PCBs t- Chloroform -- PAHs Trichloroethylene 5A 5B SC 50 SE 6A 6& 7A 7B 7C 7D 7E 8A 88 8C 80 9A SB 9C SO 9E 9F 9G 10A 1t IOC 1Q0 Potential csoddstr for subregistry of axposed perei " HMTeiqioswe. The subdaonte study should indude an extended raprocfadtvworgen Nstopathotogy. 2-epedas developmental togddtyshJdy via oral exposure _____-------------------- ------Heutotoxkokjgy battery ol tests vie cat Bpoais Epidemiological studes on the heatti effects of benzene (Spedet emphasis endpoints In- ctudsrlmmunotODddly). agioenw levels to humane fiving near hazantous waste sites and other popolsttons, such MAalejUlRll^IJ nUT-* O*iB*B- -f D PO- yCB'* JhS R.M--_ PQ WTO m---- - II<W----U----l-R-- I-V--*rai mm ........... Exposure levefe in humane firing near hazardous wests sites and other populations, such M tRpQMCf WOriWlb Domwpomdtt fttinMiloFkuI^ mcf IntsfTnsdtoto'duratiofHirafttxposures .. Biodegradation ot PCBS in water tMevababttty of PC8s in air. wetsr and sol---------- ,-- Does response data in arbmelr fcr actaa-and WermadatB-dUrabon Inhelabon ergxisuras. The subehronie study ahodd fidude extended reproductive organ histopathofogy. Epfctanbologlcat studes on the haafift attests ot FC8 (Speed enyhasis endpoints Include: gnmunowiewy, quvqmbivsi woocrj^ hon^ inyTuio woocnye ipivwMi>voovir opmentd teabdtyy. Exposure leva* fir humane firing near hazardous waste sitet and other popciabons, such as exposed workers. Dose-response del* in arwnels tortraermedtate-ftaaDon oral exposure _ ......... Epktemtofoglaf atudfss on the.heaNfr efteds ot chfcrafonn (Speed emphasis encfeoMs In- dude: cancer, neurotaxldtr. reproductive and developmentaf toxidty, hapatotnxfcity, and UAUWJJL Exposure levels fir hunwns firing near hazardous waste sfiet and other popidaBona, such Petered ranriktetetorsutxegfstrydexpoeadparsooe n..- ................................... --.. 1 Dose rejponse data fir animate ter totormedats dtsatfoo oral exposures. The subehronie study should include extended reproductive organ histopathdogy end brenunopalioiogy. ,gopwBi qpvPDpmenai mmyguoy ? irwunon or ora wipoww ....... ....................... . MecftwtjMc studas on PAHs. on how mixtures of PAHs can Influence the ultimate active- bon of PAHs, and on how PAHa affect rapidy proMferebng tissues. ! Pnae reiponie date In emmets tar acute- and irtBrmadtate-dUrafksr frihalabon expostse*. 'Tha.aubcftronic study should ineluds extended reproductive organ histopathofogy end EpkMotbgkad studtea on fha health aftecte of MHs (Speed emphasis endpoHs include: cancer, dermat. hemofymphatic. and hepaflcL Exposure levels in humans firing near hazardous waste sites and ottd populations, such as exposed workers. Potential eanddate tor subcegistry of exposed persons------------------------------------- --------- | Dose-response data In animate for acute-duration on# exposure-------------------------------- Muotogdcotogy battery of tests da the oraf route---------------------------------- ------------------- tmnwuauiuofogy battery of tests vte the onfwute -..................................... ....................} I pmnmpyM wictm- on im noonn onoca or uicniorooinyiono (opoev on^ww-- sndrthts Include: cancer, hepatotoodcfly, renef taddty, dovetoproental toxicity, and netxotoxidty). * * R&S150636 11438 Federal Register / Vol. 59. No. 47 / Thursday, March 10. 1994 / Notices Table i.--Substance-Specific Priority data Needs Currently Being addressed Under ATSDR's Appueo Research Programs--Continued Substance ID Priority Data Need Addressed 10E Exposure levels In humans tiving near hazardous waste sites and other populations, such DDT as exposed worker*. 11A Dose-response data to smnata torchroniesduBtion oral exposure ----............ -- 11B Comparative toxicokinetic study (across routes/species)---------------------------------------------- 11C Bloavailabity and bioaccumulation tram sol.............. .................... --........ -..... ..-- 11D Epidemiological sureties on the health effeefe of DDT, ODD and DDE (Special emphasis endpoints include: immunotoxlbty, reproductive and developmental toxicity). 11E Exposure levels In humans living near hazardous waste sites and other populations, such as exposed workers. Chromium 11F Potential canddate tor subregistry of exposed persons---------------------------------------------12A Dose-response data in animate lor acute duration exposve to chromium (VI) and (III) via * oral exposure and lor tatatmedaie-duraBon exposure to chromium (VI) via oral exposure. 12B Multigeneration reproductive toxicity study via oral exposure to chrooxum (III) and (VI)------ 12C Immunotoxicotogy bettary of tests following oral exposure to chromium (III) and (VI) -- 12D 2-species developmental toxicity study via oral expoeue to chromium (ill) and (VI)---------- 12E Exposure levels In humans tivtag near hazardous waste sites and other populations, such as exposed workers. Tetrachkvoethytene 13A Dose-response data in animals lor acute-duration oral sxposue, induing neuropathology and demeanor, and immunopathology. 13B Multigeneration reproductive toxicity study via oral exposure---------------------------------- --- - 13C Pose-response data in animals tor chrontoduatian oral exposure, induing neuropathology and demeanor, and toimutopelhotogy. 130 2-apeoes developmental toxicity study via oral expoeue------------------ .------------------------- 13E Exposure levels in human* living near hazardous waste sites and other populations, such as exposed workers. 13F Potential candkiato lor sttoregtetiy of exposed persooe-------------------------------------------- * Aktrin/Dieidrin___ ^ 14A Dose-response data In animals for intarmedmte-duration oral exposure----- :----------------- - 14B Bioavatiabiftty from so r--~ __ ---- ........- -- --- ---- - --- --- -- 14C Exposure levels in Humana Kvfng near hazardous waste site* and other populations, such Cyanide 140 15A - as exposed workers. v. Potential canddate for subregistry ol exposed persons------ :-------------------------------------- Doee-responee data in anttnais lor acute- and tatetmedals-duaBcn exposures via inhala tion. The subchronie study shottid include extended reproductive organ htatopathdogy and evaluation ol naurabehavioral and nauropathologlcal endpoints. 15B 2-spedaa developmental toxicity study via oral exposure------- -------------------- --...--------- 15C Evaluation of the environmental fata ol cyanide In sol_____ __________________________ 15D Exposure levels in humena living near hazardous wwste site* and other populations, such as exposed workers. Carbon Tetrachloride 156 ISA Potential canddata for subregistiy ol exposed persons-------- !------------------------------------Dose-response data In animals tor chronic oral exposure. The study should indude ex * tended reproductive organ and nervous tissue (and demeanor) histopathotogy. 16B Immunotaxtootogy battery of tests via oral exposure ...,, ~........................ ...............-.... -- 16C Half-We to son__________________________________________ 160 Expoeue levets to human* livtog near hazardous waste sties and other populations, such es exposed workers. Beryllium 16E Potential candkiato tor subregistry of exposed persons--...-------------------------------------17A Dose response data in animats lor acute- and intermodule-duration inhalation exposures. * The subchronic study should include extended reproductive organ hlstopathology. 17B 2-species developmental torictiy study via inhalation exposure------------------------------------17C Environmental fate to air; factors affecting btoavaiiabi&ty in air--------------------------------- --- 17D AnMyDGW mOtnOQi V) OOfOfTTMfW tnVIOnmPU) ^wCTIDOn ...re i.-- 17E Immunutoxicology battery of testa totiowtog oral exposure............-....--........ -I..-...... . 17F Exposure levels to humans Rvtog near hazardous waste sties and other population*, such Toluene as exposed workers. 18A Doae-response data to animata lor acute- and totermedtate-duation oral axposuea. The subchronic study should include en extended htatopatftological evaluation olthe immune system. 188 Confoarative toxicokinetic stuties (Characterization of absorption, .distribution, and excre- Bon via oral exposure). . 18C Neurotoxicology battery of testa via oral eifoaeue .------------------ .----------------------------- --- 180 Mechanism ol toluene-induced neurotoxicity..............................................................---- 18E Expoeue levels to humans livtog near hazardous waste sties and other populations, such Nickel as exposed workers. 19A Epidemiological toudes on the health effects ol nickel (Special emphasis endpoints include: reproductive toxicity). 16B 2-species developmental toxicity study via the oral route-------------------:------------------------- 19C Dose-response data to animats for acute- and totetmedate-durabon oral exposures--------- 160 Neurotoxicology battery of tests via oral exposure ------------------------------------------------------ 19E Blnevainhlgty ol nickel from so> -:___:____________________ _ 19F Exposure levels to humans lying near hazardous waste totes and other papulations, such as exposed workers. jo=j w C00D1 Ovll Federal Register / Vol 59, No, 47 / Thursday. March 10, 1994 i Notices 11439 Table i .--Substance-Specific Priority data Needs Currently Being Addressed Under ATSDR's applied Research Programs--Continued Substance ID Priority Date Need Addressed Methylene Chloride___ 2QA *" * 206 20C 200 Zinc ....____________ _ 2TA 218 2TC 21D DEHP--------------------- 22A 228 22C 220 22E Selenium___________ 22F 23A 238 23C 230 Doee-response data to animate tor acute- and iniermediate-duralwn end exposure. The subchronic study stated toduda extended reproductive organ hetopathotogy. nawopathotogy and daraaanor. andtraneawpathotogy. 2-spedes developmental toxicity study via the oral route Exposure levels in humans Svtog near hazardous waste sites and other populations, such as exposed workers. Potential canddate tor stexeghtiy of axpoaed persona ---------------------------------------------Doee-response data in animats tor anas- and totermaiiate-duration oral exposures. The subehronto study stated include an extended hetopattatogical evaluation of the immunotogic and narretoqicai systems. MWBganarstion reproductive toxicity study via oral exposure--------------------------------------Carcinogenicity testing (2-year bioassay) vie oral exposure--------- -------------------------------Exposure levels to humans Mng near hazardous waste sites and other populations, such as exposed workers. Epidemiotogicai etudes on. the health ettods of DEHP (Special emphasis endpoints indude: cancer). Dose-response data in animate for acute end tatermedate-duralion oral, exposures. The subchromc study stated include an extended Nstopathotogical evaluation of the immuwiogic and neurologic systems. MUMganeratton reproductive toxicity study vis oral exposure-------------------------------------Comparative toxicoidnedc itudee (Stories designed to examine how primates metabolize and dtoutouts DEHPas confrered to rodents via oraf exposure). Exposure tovete in humans Kving near huaedaus waste sites and other populations, such tt W^QMfWQlMlIr Dose-response data in animate for.acute-duratton oral exposure Hnmunotoxtootogy betiery of tests via oral exposure . Epidemiotogicai studee on the health eiiecte d selenium (Special emphasis endpoints In- dude: cancer, reproductive and developmental taxJdty. hepstotoxldty and adverse skin Mads). Exposure tevate in humans Iving near hazardous waste sites and othsr populations, such *r Chloroethane 23E Potential canddate tor subregistritoi exposed parsons --------------------------------------------- 24A Boas responst data in anlmato to* acuta- and totermedtete-duration oral exposures. The subetsentestudy shodd indude an evakretion ot immune end nervous system (end behavior. demeanor) tissues, and extended reprortodivw organ htetopathotogy. 248 rtoaa-rasponaedtea to anxaala to* chronic tehatetinn expoeuwi. The study should indude an evaluation oi nervous syetam (and behavior) twxeia. 24C Potential canddate to* stevegahyd exposed parsons /* >r *These substances aw inducted in the poof of eandWate substances farsitoregtetry development. These wisstance* w be considered for se lection as primary contaminants by the Oiiiteon d Haaim Studee. ATSPR. during each selection process. Table 2.--Priority data Needs being addressed by EPA Rule Making Substance ID Priority Date Need TSCA/HFRA Mercwy Vinyi ChiorM........... 36 30 48 Doeerwspooae dale in anlmato to* dsento-duratton oral exposua-------------------------- immunotoxiooiogy battery priests vis udexpusurw _ ... Benzene 5A Chromium 5C 10A W3C 12A 128 12C Tetrachioroeihyiene______ m 138 Ttoswteapons* animate to* kaomndrets dtrtaae oat exponm The wbcfcmnto study should inducts an extended reproductive organ hdtopethotogy. Neurotodcteogy battery td tastevieoraiaxpoaua----------------------------------------------- bnmunofcwicoiogy battery d teste via the oral route.......... .... - ........................-- Pose ratponsc date to animate to* acute duration expoaise to chromium(VI) and (Ul) via oralexposure. Mitegenemltcn wprodicttee tcadcity hxlyviaontetqxteMtat><homiumOH)and(VI), Immunotoxicoiogy battery d taste toPowing oral exposure to chromium (111) and (W) -- Dose response date to animate to* acteeduratie* oral exposure, indudng neuropathology snri rtwneano*, end immrmnpalhntogy ' Mtetigeneralion reproductive toxfctty study via ortetxppeum * > 130 rlaiffci-ipdntentnl tnadrity sdm. tewprttetMte . ... . TSCA. TSCA. TSCA. TSCA. TSCA. * TSCA. TSCA. TSCA. TSCA. TSCA. TSCA. TSCA (iRwiDon study). TSCA [wwmmaon study). TSCA tody). R&S150638 17.440 Federal Register / VoL 59, No. 47 / Thursday. March 10, 1994 / Notices Table 2.--Priority Data Needs Being Aodressed by EPA Rule Making--Continued Substance ID Priority Data Need TSCA/FIFRA Cyanide ISA 1SB ISC Berytkm..... ............... .... . 17A 17B 17C 17E Toluene .---------------------- 18A 188 Methylene Chloride -.... -- 20A 206 Chioroethane___________ 24A Dose-response data in animals tor acute- end totermedate-duration exposures via in halation. Tht rCacuta study should indude extended reproductive organ hgtopathdogy and evaluation ol naurobehaviorei and neuropethologicel endpoints. 2-Spedes dsvsiopmsntal toxicity study via oral exposure------------------------------ ------ Evaluation ol ths environmental tats ol cyanide In soil ..... ....--... - ......- . Dose-response data in enimala lor acute- and totermedate-duration inhalation expo- suras. The subchronie study shodd include extended reprodrctive organ histopathdogy. 2-spades developmental toxidty study via Inhalation exposue --- --------- ----...-- Environmental late in air. (acton affecting bioevailabity in air-------------------------------- Dose-response data in animals for totarmediateduration oral exposures. The study should induds an extended htmpaihoioflical evaluation oi ths Imnsme system. Comparative toMCOtonetie etudes (Characterization ol absorption, dtetritxtion, and ex- cretion via oral exposure). Dose-response date In animals tor totermedat*duation oral exposure. The study should include extended Immunopathotogy end neuropathology. 2-spedes deveiopmenai toxicity study via the oral routs ................. - ....---------;-------- Dose-response data in animals for acute- and totermedate-duration oral exposures. The subchronie study should include an evaluation of immune and nervous system (and behavior, demeanor) tissues, end extended reproductive organ histopathotogy. %' T TSCA. TSCA (inhalation study). TSCA. TSCA. TSCA. TSCA. TSCA (inhalation study). TSCA. TSCA. TSCA. TSCA. TSCA. (EPA tviff only address the immune system requirement of this Priority Data Need) Table 3.--priority Data needs Potentially Being Addressed by Voluntahy research Substance v" PCBS. Methylene cNorida ID 78 7E 20A 208T Priority data need Finn Biodegradation of PCBs In Epidemiological stodtos on Km health eftects of PC8s (Special em phasis endpoints inctode: knmunotaxicity, gastrointestinal. toxicity, Iver, kidney, thyfdd, toxicity, reproductivafdeveiopnwntaL toxicity). Doee-responee data in animals tor acute- and totetmedate-duration oml expoewe. The subchronic study should todude extended re productive organ Itotopathotogy. neurapethoiogy and demeanor, and imnsnopathotogy. 2-speciea developmental toxicity study via the orai touts-------------- General Electric Company. General Electric Company. Haiogenated Solvents industry Alliance. Haiogenated Solvents Industry Alliance. Substance Lead - Mercury Benzene -- PAHs Trichioroeihytens Tabu 4.--Priority data Needs Being Addressed by MHPF Institutions to 1A 1C 3A 58 9A 90 ... 106 Priority data need ' -- nsBDjBon Mechanistic etudes on the newotoxfo effects of toad _. Florida A AM University. Texas Southern University. Exposue ieveie in humane Mng near hazardous The HnglDrew Medcal Center of the Chattel R. waste sites and ether populations, such as exposed Drew University of Meddne and Science. workers, t Morehouse School of Meddne. Mdtigenerstion reproductive toxicity study via oral ex Tuskegee University. posure. 2-spedes deveiopmentai tooddty study via oral expo Xavier University. sure. Dose-response data in'animats for toterroedale dura Mehany Medcal CoBegs. tion oral exposures. The stfochronie study should in- dude extended reproductive organ histopathotogy and tosnunopaUrotogy. Dose-response data in animals tor acute- and inter- Meharty Medcal College. medale-dutation inhalation exposures. . Ths sttochronic study shotid toduds extended Mproduotive organ histopalhoiogy end Immunopathotogy. - (Jo 05 Neuotoxioology battery of teste via oral eagtoeura------ Texas Southern University. . g <y> CO CD Federal Register / Vol. 59, No. 47 / Thursday, March 10, 1994 / Notices 11441. Table 4.--priority Data Needs Being Addressed by MHPF institutions--Continued SrAwtance Toluene Zinc 1 ID 18C 21A Priority data need Institution Neurotoxioology battery at tests vie oral exposure Dose-response data In animals lor acute- and inter- medtete-duration oral exposures. Trie stDcrironc study should include an extended histopalhoiogical evaluation of trie immunologic and neurological sys tems. Texas Southern University. Xavier University. Tuskegee University. Table 5.--Priority Data needs Being Addressed by the ATSOR Great Lakes Homan Health effects Research program Substance ID Priority data need Institution Lead Mercury PCBl PAHs DDT 1C Exposure levels in humans living State University of New York at Buffalo. near hazardous waste sitae and State University of New York at Oswego. othsr populations, such as ex Michigan State University. posed workers. University ot Wisconsin--Superior. New York State Health Department University of NHnote at Chicago. University of USnois at Urbane-Champaign. Wisconsin Department of Heelth end Soctal Services. 3A Multigeneration reproductive toxicity Stats University of New Yortc at Oswego. study vie oral exposure. University ot nmols at Chicago. 30 Exposure, levels in humene Rving State University ol New York at Buffalo. new hazardous waste shea and State University of New York at Oswego. othsr populations, such as ex- Michigan Stats University. DOttd wortean. University olWtecondn--Steterior. New York Stele Health Department University ol Wnoie at Chicago. Urvversity ol IMnoiS at Uibara-Champalgn. Wisconsin Department of Health and Social Services. 3E Potential cancRdate for subregistry of Wisconsin Department of Henri and Sodei Services. expossd persons. 7A Dose-response data in animate lor University ot Wisconsin--Superior. * acuta and intatmedtats-dunttion oral exposures. 7E tpwwwnQKii mm on ms nwin Stats University ot New York at Buffalo. effects at PC8e (special emphasis State University ot New York at Oswego. endpointi indudr Immunotoxlclty. University of Wisconsin--Siawrior. gastrointestinal toxicity. War. kid University of IMnois at Chicago. ney. thyroid toodcRy, reproductive/ University of Illinois at UrtoemCharnpaiga oovviopmonuu vooocsyv - 7F Exposure levels in. humans ffving State University of New York at Buffalo. near hazardous waste sites and State University of New York at Oswego. - .. other pnputetione, such as ex Michigan State University. posed workers. f University of Wisconsin--Superior. V New Yoik State Health Department University ol Illinois at Chicago. University of URnote at Urbane-Champaign. ~ Wisconsin Department of Health and Social Services. 9E Epidemiological studtes on the health Wisconsin Department of Healthand Social Services. Irani ov rAm (spvcrai inpww endpoints indudit cinoir dinral, hemoiymphatic, and hepatic). 9F Expoetae levels In humane Rving Wisconsin Department of Health and Social Services. near hazardous waste sites and othsr populations, such as ex- posed workers. 11D cPOwhioioqcb smses on mo noun State University of New York at Buffalo. effects ol DDT. DOO and ODE State University of New York at Oswego. (special emphasis endpoints- in Michigan State University. clude: Immuxitoxicity. reprcducttve University of Uinois at Chicago. and developmental toxicity). Wisconsin Department of Health and Social Services. 11E Exposure levels in humans Rving Stela University of New York at Buffalo. - new hazardous waste sites and State University of New York at Oswego. other popOaflons. such as ex Michigan State University. posed workers. University ot USnois >1 Chicago. Wisconsin Department of Health and Social Servioss. 11F Poterdei candttste tor subregistiy at Wisconsin Department of Health and Sodal Services. exposed persons. IFR Doc. H-UM FW 3-#-04; MStml MLUNO COOS *--* R&s 150640 WedU Sept.5,1990/Pago ` 6*C Dow's agreement on fine Pr settle old U.S. suit By John Capitol ' fy Frank Main/ State-Times writer , -. - ,, 1 ...... ' - -V' , , -^ , Dow Chemical Co. has agreed to pay a $38,000 fine to settle a 5-year-old > lawsuit by the government that alleges the company's Plaquemine plant .-'illegally released toxic vinyl chloride into the environment ','jfconsent decree filed Friday inlLS. District Court in Baton Rouge gives , Dow Chemical a month to pay. the fine. , >>The U.S. Environmental Protection Agency sued Dow in March 1985, clmrning the company violated the Clean Air Act .. >... , ; ' Dow agreed to pay $87,000 in an October 1987 consent decree, settling the ' EPA's original allegation that the company was responsible for 12 releases otOinyl chloride between 1980 and 1983. !Vinyl chloride is a known cancer-causing agent. At the time of the alleged 1 *{Violations, the EPA was enforcing a zero-emissions standard;on;the r ^^^Hto^^ciohseht deo^sig^ byUADto^n^i^W-^^eri f ?.. The | 'eausmi Southv highly, commt nationt college Puli', Romtv a wee becau: "appo pledge 'consti ;].andLe ! from an amended complaint filed bytteEPAin Augustjl986 that I d 13 more relief-valve dischargesef vinyl cfalortde aB^S^eporting $- ^state.if - violationsbetween 1980and 1983. . .....: rj cor r i:Oow lawyer Dean Cooper said the vinyl chloride was released through ' safety values and incinerated in a flare tower. "! "The low amount of the penalty shows that the EPA felt that the flare was effective in removing the majority of the vinyl chloride," be said. "But they had to fine us because it was a technical violation. . .Unfortunately, a lot of .Companies were allowing those valves to discharge into the environment; -f * directly." `EPA spokesman David Bary said federal regulations have changed to i allow chemical plants to burn off vinyl chloridein flare towers that meet II, mu local, g Louisia Romi inUSL'i " Hesa sign the bureau* j. government standards. *w/' . igary agreed with Cooper that the government would not bring a similar V- ,,rliwsuit against Dow today under the EPA's current regulations. Jt^JJnder federal law; the public has 30 days to comment on last wieek's .; /fcieiisent decree.- The government could postpone the settlemqnt if any f; `f comments warrant further investigation. ; ' ........................ ......... .. " 4!^--1- - ^i; -r-. &=?. J3 po 05 00011