Update on the Status of the Superfund Substance-Specific Applied Research Program, 71506-71531 [05-23361]

Download as PDF 71506 Federal Register / Vol. 70, No. 228 / Tuesday, November 29, 2005 / Notices A. Purpose This information requirement consists of reports that do not impose collection burdens upon the public. These collections require information which is already available to the public at large or that is routinely exchanged by firms during the normal course of business. A general control number for these collections decreases the amount of paperwork generated by the approval process. GSA has published rules in the Federal Register that fall under information collection 3090–0250. The rule that prescribed clause 552.238–70 ‘‘Identification of Electronic Office Equipment Providing Accessibility for the Handicapped’’ was published at 56 FR 29442, June 27, 1991, titled ‘‘Implementation of Public Law 99– 506’’, with an effective date of July 8, 1991; and Clause 552.238–74 ‘‘Industrial Funding Fee and Sales Reporting’’ published at 68 FR 41286, July 11, 2003. B. Annual Reporting Burden None. OBTAINING COPIES OF PROPOSALS: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat (VIR), 1800 F Street, NW., Room 4035, Washington, DC 20405, telephone (202) 208–7312. Please cite OMB Control No. 3090–0250, Zero Burden Information Collection Reports, in all correspondence. Dated: November 21, 2005. Gerald Zaffos, Director, Contract Policy Division. [FR Doc. 05–23432 Filed 11–28–05; 8:45 am] BILLING CODE 6820–61–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Toxic Substances and Disease Registry [ATSDR–215] Update on the Status of the Superfund Substance-Specific Applied Research Program Agency for Toxic Substances and Disease Registry (ATSDR), U.S. Department of Health and Human Services (HHS). ACTION: Notice. AGENCY: SUMMARY: This Notice provides the status of ATSDR’s Superfund-mandated Substance-Specific Applied Research Program (SSARP) which was last VerDate Aug<31>2005 20:13 Nov 28, 2005 Jkt 208001 updated in a Federal Register notice in 2002 (67 FR 4836). Authorized by the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA, also known as the Superfund statute), as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA) [42 U.S.C. 9604 (i)], this research program was initiated on October 17, 1991. At that time, a list of priority data needs for 38 priority hazardous substances frequently found at waste sites was announced in the Federal Register (56 FR 52178). The list was subsequently revised based on public comments and published in final form on November 16, 1992 (57 FR 54150). The 38 substances, each of which is found on ATSDR’s Priority List of Hazardous Substances (68 FR 63098, November 7, 2003), are aldrin/dieldrin, arsenic, benzene, beryllium, cadmium, carbon tetrachloride, chloroethane, chloroform, chromium, cyanide, p,p′DDT,DDE,DDD, di(2-ethylhexyl) phthalate, lead, mercury, methylene chloride, nickel, polychlorinated biphenyl compounds (PCBs), polycyclic aromatic hydrocarbons (PAHs— includes 15 substances), selenium, tetrachloroethylene, toluene, trichloroethylene, vinyl chloride, and zinc. On July 30, 1997, priority data needs for 12 additional hazardous substances frequently found at waste sites were determined and announced in the Federal Register (62 FR 40820). The 12 substances, each of which is included in ATSDR’s Priority List of Hazardous Substances, are chlordane, 1,2-dibromo3-chloropropane, di-n-butyl phthalate, disulfoton, endrin (includes endrin aldehyde), endosulfan (alpha-, beta-, and endosulfan sulfate), heptachlor (includes heptachlor epoxide), hexachlorobutadiene, hexachlorocyclohexane (alpha-, beta-, delta- and gamma-), manganese, methoxychlor, and toxaphene. More recently, priority data needs for 10 additional hazardous substances frequently found at waste sites were determined and announced in the Federal Register (68 FR 22704). The ten substances, each of which is included in ATSDR’s Priority List of Hazardous Substances, are asbestos, benzidine, chlorinated dibenzo-p-dioxins, 1,2dibromoethane, 1,2-dichloroethane, 1,1dichloroethene, ethylbenzene, pentachlorophenol, 1,1,2,2tetrachloroethane, and total xylenes. Currently, the priority data needs for acrolein and barium are being identified and will be reported in a future Federal Register notice. PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 To date, 270 priority data needs have been identified for the 60 hazardous substances, and 86 priority data needs have been filled (Table 1). ATSDR fills these research needs through U.S. Environmental Protection Agency (EPA) regulatory mechanisms (test rules), private-sector voluntarism, and the direct use of CERCLA funds. Additional priority data needs are being addressed through collaboration with the National Toxicology Program (NTP), by ATSDR’s Great Lakes Human Health Effects Research Program, and other Agency programs. Priority data needs documents describing ATSDR’s rationale for prioritizing research needs for each substance are available. See ADDRESSES section of this Notice. This Notice also serves as a continuous call for voluntary research proposals. Private-sector organizations may volunteer to conduct research to address specific priority data needs identified in this Notice by indicating their interest through submission of a letter of intent to ATSDR (see ADDRESSES section of this Notice). A TriAgency Superfund Applied Research Committee (TASARC) composed of scientists from ATSDR, National Institute of Environmental Health Sciences (NIEHS)/NTP, and the EPA, will review all proposed voluntary research studies. ATSDR provides updates on the status of its Substance-Specific Applied Research Program approximately every three years or sooner, as needed. ATSDR considers the voluntary research effort to be important to the continuing implementation of the SSARP. Therefore, the Agency strongly encourages private-sector organizations to volunteer at any time to conduct research to fill data needs until ATSDR announces that other research mechanisms are in place to address those specific data needs. DATES: Private-sector organizations interested in volunteering to conduct research can write to Yee-Wan Stevens, M.S., Applied Toxicology Branch, Division of Toxicology and Environmental Medicine, ATSDR, 1600 Clifton Road, NE., Mailstop F–32, Atlanta, Georgia 30333, e-mail: YStevens@cdc.gov. Information about pertinent ongoing or completed research that may fill priority data needs cited in this Notice should be similarly addressed. Other Requirements: Projects that involve the collection of information from ten or more individuals and funded by cooperative agreement will be subject to review by the Office of ADDRESSES: E:\FR\FM\29NON1.SGM 29NON1 Federal Register / Vol. 70, No. 228 / Tuesday, November 29, 2005 / Notices Management and Budget (OMB) under the Paperwork Reduction Act. FOR FURTHER INFORMATION CONTACT: YeeWan Stevens, M.S., Applied Toxicology Branch, Division of Toxicology and Environmental Medicine, ATSDR, 1600 Clifton Road, NE., Mailstop F–32, Atlanta, Georgia 30333, telephone: (770) 488–3325, fax: (770) 488–4178. SUPPLEMENTARY INFORMATION: Background CERCLA as amended by SARA [42 U.S.C. 9604(i)] requires that ATSDR (1) jointly with the EPA, develop and prioritize a list of hazardous substances found at National Priorities List (NPL) sites, (2) prepare toxicological profiles for these substances, and (3) assure the initiation of a research program, in conjunction with NTP, to address identified data needs associated with the substances. Before starting such a program, ATSDR will consider recommendations of the InterAgency Testing Committee on the type of research that should be done. This committee was established under section 4(e) of the Toxic Substances Control Act of 1976 [15 U.S.C. 2604(e)](TSCA). The major goals of the ATSDR SSARP are (1) to address the substance-specific information needs of the public and scientific community, and (2) to supply information necessary to improve the database used to conduct comprehensive public health assessments of populations living near hazardous waste sites. We anticipate that the information will help to establish linkages between levels of contaminants in the environment and levels in human tissue and organs associated with adverse health effects. Once such links have been established, strategies to mitigate potentially harmful exposures can be developed. This program will also provide data that can be generalized to other substances or areas of science, including risk assessment of chemicals, thus creating a scientific information base for addressing a broader range of data needs. ATSDR encourages the use of in vitro assessment methods and other innovative tools for filling priority data needs. For example, the Agency believes that physiologically based pharmacokinetic (PBPK) modeling could serve as a valuable tool in predicting across route similarities (or differences) in toxicological responses to hazardous substances. Therefore, on a case-by-case basis, a priority data need can be filled using existing data and modeling. In addition, ATSDR is a VerDate Aug<31>2005 20:13 Nov 28, 2005 Jkt 208001 member of NTP’s InterAgency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and supports development, validation, and acceptance of alternative toxicological test methods that reduce, refine, and replace the use of animals, as appropriate. CERCLA section 104(i)(5)(D) states that it is the sense of Congress that the costs for conducting this research program ‘‘be borne by the manufacturers and processors of the hazardous substance in question,’’ as required in TSCA and the Federal Insecticide, Fungicide, and Rodenticide Act of 1972 [7 U.S.C. 136 et seq.] (FIFRA), or by cost recovery from responsible parties under CERCLA. To execute this statutory intent, ATSDR developed a plan whereby parts of the SSARP are being conducted via the regulatory mechanisms referenced (TSCA/FIFRA), private-sector voluntarism, and the direct use of CERCLA funds. The TASARC, composed of scientists from ATSDR, NIEHS/NTP, and EPA, has been set up to: (1) Advise ATSDR on the assignment of priorities for mechanisms to address data needs, (2) Coordinate knowledge of research activities to avoid duplication of research in other programs and under other authorities, (3) Advise ATSDR on issues of science related to substance-specific data needs, and (4) Maintain a scheduled forum that provides an overall review of the ATSDR SSARP. TASARC has met 12 times since the initiation of the SSARP. It has guided referral of priority data needs to EPA and the associated development of test rules through TSCA. In addition, it has endorsed the proposals of several private-sector organizations to conduct voluntary research. Furthermore, TASARC has become a forum for other federal agencies to bring forth their research agendas. For example, it has coordinated research efforts on hazardous pollutants with the Office of Air and Radiation, EPA. TASARC has developed testing guidelines for immunotoxicity; and has endorsed the use of decision-support methodologies such as physiologically based pharmacokinetic (PBPK) modeling and benchmark-dose modeling, where appropriate. Additional priority data needs are being addressed through collaborative research efforts with NTP, by ATSDR’s Great Lakes Human Health Effects Research Program, and other Agency programs. PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 71507 Criteria for Evaluating Status of Priority Data Needs To update the activities covered under the SSARP, criteria for evaluating the status of the priority data needs were developed. Based on these criteria and the review of the current literature, a priority data need can be filled, or unchanged. The criteria for evaluating the status of the priority data needs are described below. General Criteria A priority data need is filled: • If it has been referred to one of the implementation mechanisms and research has been initiated (Exception: priority data needs referred to EPA [i.e., included in the EPA/ATSDR test rule] and/or ATSDR Voluntary Research Program remain as priority data needs until the studies have been completed, peer reviewed and accepted by ATSDR), or • If an updated ATSDR toxicological profile contains relevant new studies, or if other relevant, peer-reviewed, and publicly available new studies (not included in the toxicological profile) have been identified since the finalization of the priority data needs document; and based on such studies, it is generally agreed that a priority data need has been filled. Furthermore, in the event a priority data need is considered filled, it does not necessarily mean that the study has been completed and that ATSDR has accepted the data. It does, however, indicate that the Agency no longer considers it a priority to initiate additional studies at this time. A priority data need remains unchanged: • If no mechanism or information has been identified to address the priority data need, or • If the priority data need is included in the ATSDR/EPA test rule under development and/or ATSDR Voluntary Research Program, or it is associated with a pilot substance in EPA’s Voluntary Children’s Chemical Evaluation Program. Specific Criteria Examples of specific criteria for two categories of priority data needs are described below. • Epidemiologic studies—A priority data need is filled if multiple new studies assessing key health end points are available in ATSDR’s updated toxicological profile and/or ongoing studies have been identified, e.g., human health studies supported by ATSDR’s Great Lakes Human Health E:\FR\FM\29NON1.SGM 29NON1 71508 Federal Register / Vol. 70, No. 228 / Tuesday, November 29, 2005 / Notices Effects Research Program or the Minority Health Professions Foundation Research Program. In some cases, ATSDR indicates that it will continue to evaluate new data as they become available to determine whether additional studies are needed. • Exposure levels in humans (adults and/or children)—A priority data need is filled if (a) there are current and adequate biomonitoring data for exposed populations associated with health effects (from published or ongoing studies), or (b) there are reference range data (e.g., the Centers for Disease Control and Prevention’s Third National Report on Human Exposure to Environmental Chemicals, with data from a random sample of participants from the National Health and Nutrition Examination Survey [NHANES]) or generally agreed upon background population levels. In the latter case, ATSDR acknowledges that reference concentration data can support exposure and health assessments at waste sites, but the Agency also continues to recognize the importance of collecting additional data on uniquely exposed populations at waste sites. It should be noted that for some of the chemicals listed in the National Report, the measurements are reported as below the limit of detection (LOD) for those chemicals. However, the LODs for all the chemicals monitored are available in the Report, and therefore, these data can be considered as estimates of background exposure levels. In updating the SSARP, the status of the priority data needs may change as new information becomes available. Further, during the literature review, new studies may be identified suggesting other effects of concern, such as those related to endocrine disruptors and children’s health, which were not included in the original list of priority data needs. In such cases, additional priority data needs may be added to the research agenda. For example, in addressing issues relating to children’s health, ATSDR considers it a priority to obtain data on exposure levels in children; therefore, when such information is available, it is used to fill this additional priority data need (e.g., cadmium, chlordane, chlorinated dibenzo-p-dioxins, DDT, lead, and pentachlorophenol, see Table 1). In contrast, the Agency may consider a previously identified priority data need to no longer be a priority to fill at this time and thus be deleted from the list of priority data needs. However, it remains a data need for the Agency. For example, as a result of reevaluation of the database for di-n-butyl phthalate, VerDate Aug<31>2005 20:13 Nov 28, 2005 Jkt 208001 two of its previously identified priority data needs, i.e., immunotoxicity and neurotoxicity studies via oral exposure are no longer considered to be priority data needs. This is due to the fact that the immune system does not appear to be a target for di-n-butyl phthalate toxicity and that additional neurotoxicity studies do not seem necessary because of the lack of effects seen in long-term neurotoxicity studies. In addition, under the Agency’s Voluntary Research Program, the Halogenated Solvents Industry Alliance, Inc. (HSIA) proposed to fill a trichloroethylene priority data need (dose-response data for intermediateduration, oral exposure) by conducting PBPK modeling to obtain the data for oral exposure using existing inhalation data. However, ATSDR is concerned that, based on the existing data for this exposure duration, it is not clear if the most sensitive end point for oral exposure is the same as that for inhalation exposure. Therefore, the Agency believes it is prudent not to consider it a priority to conduct a PBPK study to obtain the oral data at this time pending evaluation of additional information. This is reflected in Table 1 from which this priority data need has been deleted. Update of Activities in the SSARP An update of the activities associated with the mechanisms for implementing the ATSDR Substance-Specific Applied Research Program (SSARP) is discussed below. A. TSCA/FIFRA In developing and implementing the SSARP, ATSDR, NIEHS/NTP, and EPA have identified a subset of priority data needs for substances of mutual interest to the federal programs. These priority data needs are being addressed through a program of toxicological testing under TSCA according to established procedures and guidelines. On several occasions when ATSDR identified priority data needs for oral exposure, other agencies needed inhalation data. In response, ATSDR considers proposals to conduct inhalation studies in conjunction with physiologically based pharmacokinetic (PBPK) studies in lieu of oral studies. ATSDR expects that inhalation data derived from these studies can be used with PBPK modeling to address its oral toxicity priority data needs. Currently, an EPA/ ATSDR test rule, under development, includes eight ATSDR substances, i.e., benzene, chloroethane, cyanide (hydrogen cyanide and sodium cyanide), methylene chloride, tetrachloroethylene, toluene and PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 trichloroethylene, and addresses 13 ATSDR priority data needs (Table 2). The test rule is presently undergoing ATSDR and EPA final review and is anticipated to be available for public comment in Spring 2006. At least seven metals included in the ATSDR’s SSARP (arsenic, beryllium, chromium, manganese, mercury, nickel, and selenium, associated with 21 priority data needs) (Table 2) have been forwarded to EPA through TASARC for toxicity testing. The EPA is currently developing a risk assessment framework for metals. Once the framework has been adopted, the EPA will solicit testing proposals for these metals and pursue appropriate testing mechanisms at a later date. B. Private-Sector Voluntarism As part of the Substance-Specific Applied Research Program (SSARP), ATSDR announced a set of proposed procedures for conducting voluntary research in the Federal Register (57 FR 4758) on February 7, 1992. Revisions based on public comments were published on November 16, 1992 (57 FR 54160). Private-sector organizations are encouraged to volunteer to conduct research to fill specific priority data needs at no expense to ATSDR. All study protocols and final reports are subjected to ATSDR’s external peer review, and ATSDR accepts the study results based on the peer reviewers’ recommendation and the industry groups’ satisfactory response to the reviewers’ comments. To date, ATSDR has established memoranda of understanding with four industry groups. Through the voluntary research efforts of these organizations, at least 15 research needs (12 priority data needs and 3 data needs) for methylene chloride, tetrachloroethylene (perchloroethylene), trichloroethylene, polychlorinated biphenyl compounds [PCBs], and vinyl chloride have been or are being filled (Table 2). Industry groups which conducted studies under the Voluntary Research Program include: The American Chemistry Council (ACC) [Formerly the Chemical Manufacturers Association (CMA)] ATSDR accepted the ACC studies ‘‘Vinyl chloride: Combined inhalation two-generation reproduction and developmental toxicity study in CD rats.’’ General Electric Company (GE) GE conducted studies on polychlorinated biphenyls including ‘‘An assessment of the chronic toxicity and oncogenicity of Aroclors 1016, E:\FR\FM\29NON1.SGM 29NON1 Federal Register / Vol. 70, No. 228 / Tuesday, November 29, 2005 / Notices 1242, 1254, and 1260 administered in diet to rats,’’ ‘‘PCB congener analyses,’’ and ‘‘Metabolite detection as a tool for determining naturally occurring aerobic PCB biodegradation.’’ Although these studies do not specifically address ATSDR’s priority data needs for PCBs, they do address other Agency research needs for these substances. Halogenated Solvents Industry Alliance, Inc. (HSIA) To date, ATSDR has entered into five MOUs with HSIA to conduct studies to fill priority data needs for methylene chloride, tetrachloroethylene and trichloroethylene. In addition, in 2002, HSIA signed a letter of agreement with ATSDR stating that HSIA volunteers to conduct studies to fill ATSDR’s remaining priority data needs for tetrachloroethylene (perchloroethylene) and trichloroethylene. These studies are being done in conjunction with the EPA/ATSDR test rule and EPA’s Voluntary Children’s Chemical Evaluation Program. In some cases, HSIA first conducted a study via inhalation which was followed by route extrapolation via PBPK modeling to obtain data for oral exposure. This is because, for specific chemicals, EPA requires inhalation data while ATSDR has determined that ingestion of contaminated environmental media is the primary exposure route at hazardous waste sites. HSIA studies accepted by ATSDR include: ‘‘Addressing priority data needs for methylene chloride with physiologically based pharmacokinetic modeling’’ which evaluates acute- and subchronicduration toxicity and developmental toxicity via oral exposure. ‘‘Methylene chloride: 28 day inhalation toxicity study in the rat to assess potential immunotoxicity.’’ ‘‘Immunotoxic potential of orally administered dichloromethane from immunotoxicity studies conducted by the inhalation route.’’ (PBPK modeling) ‘‘Trichloroethylene: Inhalation developmental toxicity study in CD rats.’’ HSIA will conduct PBPK modeling to obtain data for oral exposure based on the inhalation data. ‘‘Trichloroethylene (TCE): Immunotoxicity potential in CD rats following a 4-week vapor inhalation exposure.’’ The final report of the study is undergoing ATSDR’s external peer review. Pending ATSDR’s acceptance of the inhalation study, HSIA will conduct PBPK modeling to obtain data for oral exposure based on the inhalation data. ‘‘Perchloroethylene: Study of effects on embryo-fetal development in CD rats by inhalation administration.’’ HSIA VerDate Aug<31>2005 20:13 Nov 28, 2005 Jkt 208001 will conduct PBPK modeling to obtain data for oral exposure based on the inhalation data. Electric Power Research Institute, Inc. (EPRI) In addition to the substance-specific MOUs described above, ATSDR also signed an MOU with EPRI to conduct a study ‘‘Validation of test methods for assessing neurodevelopment in children.’’ In this particular case, ATSDR and three other federal agencies (the Food and Drug Administration, EPA, and NIEHS) were also funding partners. C. CERCLA-Funded Research (Minority Health Professions Foundation Research Program) During FY 1992, ATSDR announced a $4 million cooperative agreement program with the Minority Health Professions Foundation (MHPF) to support substance-specific investigations. A not-for-profit Internal Revenue Code 501(c)(3) organization, the MHPF comprises 11 minority health professions schools at historically black colleges and universities. The MHPF mission is to research health problems that disproportionately affect poor and minority citizens. The purpose of the cooperative agreement was to address substance-specific data needs for priority hazardous substances identified by ATSDR. In addition, the agreement strengthened the environmental health research opportunities for scientists and students at MHPF member institutions and enhanced existing disciplinary capacities to conduct research in toxicology and environmental health. The MHPF published a report, ‘‘Environmental Health and Toxicology Research Program: Meeting Environmental Health Challenges Through Research, Education, and Service,’’ that describes the research findings and other successes from the first 5 years of the program. In the first five year project period that concluded during FY 1997, nine priority data needs for 21 priority hazardous substances and 22 other research needs for these and other substances were addressed. Research initiated in the second 5-year project period included studies to address 10 additional priority data needs for chlordane, di-n-butyl phthalate, lead, manganese, the polycylic aromatic hydrocarbons (PAHs), zinc, and eight other research needs. To date, 14 priority data needs have been filled through this cooperative agreement (Table 1). During 2003, ATSDR announced a new five year cooperative agreement PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 71509 program with the MHPF. The purpose of the program is to apply findings from the previous ten year environmental health and Toxicology Research Program and to improve public health and environmental medicine in lowincome and minority communities. The new program builds on earlier efforts and expands the Program’s public environmental health impact on affected communities. Activities across the following four research and environmental public health focus areas were funded to initiate this new program: substance-specific toxicology research, environmental exposure assessment, community-based environmental health education, and environmental health education for primary-care providers. No additional priority data needs are being addressed under this new program. To date, Program research findings and other activities have resulted in the publication of more than 50 manuscripts in peer-reviewed journals. The institutions which have received awards and their respective studies are listed in Table 2. D. National Toxicology Program (NTP) Section 104(i)(5) of CERCLA directs the administrator of ATSDR (in consultation with the administrator of EPA and agencies and programs of the Public Health Service) to assess whether adequate information on the health effects of priority hazardous substances found at NPL sites is available. Where adequate information is not available, ATSDR, in cooperation with the National Toxicology Program (NTP), is required to assure the initiation of a program of research designed to determine these health effects (and techniques for developing methods to determine such health effects). ATSDR continues to collaborate with NTP to address priority data needs of mutual interest. Chemicals for which NTP has conducted studies (or is in the process of conducting studies) to fill ATSDR’s priority data needs include carbon tetrachloride, 1,1dichloroethene, di-n-butyl phthalate, disulfoton, and heptachlor (Table 2). E. Great Lakes Human Health Effects Research Program Some of the priority data needs identified in the SSARP have been independently identified as research needs through the ATSDR Great Lakes Human Health Effects Research Program, a separate research program. In support of the Great Lakes Critical Programs Act of 1990, ATSDR announced in Fiscal Year 1992 the availability of $2 million for a grant E:\FR\FM\29NON1.SGM 29NON1 71510 Federal Register / Vol. 70, No. 228 / Tuesday, November 29, 2005 / Notices program to conduct research on the potential for short- and long-term adverse health effects from consumption of contaminated fish from the Great Lakes basin. Research undertaken through this program is intended to build on and amplify the results of past and ongoing fish consumption research in the Great Lakes basin. The ATSDRsupported research projects focus on known high-risk populations to define further the human health consequences of exposure to persistent toxic substances (PTSs) identified in the Great Lakes basin. These at-risk populations include sport anglers; African Americans, Asians and other nonEnglish speaking populations; pregnant women; fetuses, nursing infants, and children of mothers who consume contaminated Great Lakes sport fish; the elderly, and the urban poor. To date, the research activities of the ATSDR Great Lakes Human Health Effects Research Program have resulted in 70 publications in peer-reviewed journals. Currently, 14 priority data needs for 24 priority hazardous substances (including 15 PAHs) identified in the SSARP are being addressed through this program. The institutions which have received awards and their respective studies are listed in Table 2. F. Other ATSDR Programs In its role as a public health agency addressing environmental health, ATSDR may collect human data to validate substance-specific exposure and toxicity findings. The need for additional information on levels of contaminants in humans has been identified, and remains as a priority data need for 59 of the 60 priority substances (Table 1). In some cases, ATSDR anticipates obtaining this information through exposure and health effects studies, and through establishing and using substancespecific subregistries of people within the Agency’s National Exposure Registry who have potentially been exposed to these substances. Regarding the priority data need for exposure subregistries, the list of the 60 priority hazardous substances in the SSARP was forwarded to ATSDR’s Division of Health Studies for consideration as potential candidates for subregistries of exposed persons, based on criteria described in its 1994 document, ‘‘National Exposure Registry: Policies and Procedures Manual (Revised),’’ Agency for Toxic Substances and Disease Registry, Public Health Service, U.S. Department of Health and Human Services, Atlanta, Georgia, NTIS Publication No. PB95–154571. Currently, ATSDR has established exposure subregistries for benzene, dioxin, 1,1,1-trichloroethane (not included in the SSARP), trichloroethylene, and tremolite asbestos. G. Conclusion The results of the research conducted via the SSARP are expected to provide information necessary to improve the database used to conduct comprehensive public health assessments of populations living near hazardous waste sites. The information will enable the Agency to establish linkages between levels of contaminants in the environment and levels in human tissue and organs associated with adverse health effects, ultimately helping to determine methods for interdicting exposure and mitigating toxicity. This program will also provide data that can be generalized to other substances or areas of science, including risk assessment of chemicals, thus creating a scientific information base for addressing a broader range of data needs. The Agency plans to provide an update on the status of this research program approximately every three years or sooner, as needed. Dated: November 17, 2005. Kenneth Rose, Acting Director, Office of Policy, Planning, and Evaluation, National Center for Environmental Health, Agency for Toxic Substances and Disease Registry. TABLE 1.—ATSDR’S SUBSTANCE-SPECIFIC PRIORITY DATA NEEDS FOR 60 PRIORITY HAZARDOUS SUBSTANCES Substances PDN ID 1 PDN description Program 2 Status change 3 Comments 4 Aldrin/Dieldrin ................................ 1A ......... Dose-response data in animals for intermediate-duration oral exposure. Bioavailability from soil. Exposure levels in humans living near hazardous waste sites and other populations, such as exposed workers. .................. Filled ........ An MRL was derived in the 2000 updated ATSDR toxicological profile. .................. .................. This priority data need, previously addressed in a study in the Great Lakes Research Program, is no longer investigated in that study. Potential candidate for subregistry of exposed persons. Comparative toxicokinetic studies to determine if an appropriate animal species can be identified. Half-lives in surface water, groundwater. Bioavailability from soil ................ ATSDR. 1B ......... 1C ........ 1D ........ Arsenic .......................................... 2A ......... 2B ......... 2C ........ VerDate Aug<31>2005 20:13 Nov 28, 2005 Jkt 208001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 EPA. EPA. EPA. E:\FR\FM\29NON1.SGM 29NON1 71511 Federal Register / Vol. 70, No. 228 / Tuesday, November 29, 2005 / Notices TABLE 1.—ATSDR’S SUBSTANCE-SPECIFIC PRIORITY DATA NEEDS FOR 60 PRIORITY HAZARDOUS SUBSTANCES— Continued PDN ID 1 Asbestos ....................................... PDN description Program 2 Status change 3 Comments 4 2D ........ Substances Exposure levels in humans living near hazardous waste sites and other populations, such as exposed workers. G. Lakes .. Filled ........ In addition to the data from the Great Lakes Research Program, background level data are available in ATSDR’s 1993 toxicological profile, and at least seven ATSDR studies that evaluated urine arsenic levels and potential adverse health effects are available. Also, additional studies are available in ATSDR’s 2000 updated toxicological profile. 3A ......... Epidemiologic studies of individuals occupationally exposed to asbestos levels lower than those experienced before the institution of current occupational standards governing the use of asbestos, but higher than current levels in the general population. These studies should be performed in conjunction with the immunotoxicity studies. Immunotoxicity studies of individuals occupationally exposed to asbestos. Development of human and rat lung retention models to aid in extrapolating between rat and human data. Improved analytical methods for screening samples and determining the chemical structure of asbestos fibers. Also, techniques are needed to normalize studies in which different analytical methods were employed. Exposure levels, fiber size distribution, and asbestos fiber type in areas with natural geologic deposits of friable asbestos and at hazardous waste sites. Also, techniques for estimating air levels of asbestos from soil concentrations and activity scenarios. Exposure levels in humans living near hazardous waste sites and in other populations, such as humans living in areas with naturally high levels of friable asbestos. Potential candidate for subregistry of exposed persons. ATSDR .... Filled ........ EPA ......... .................. ATSDR established registry to follow the health of people who were exposed to asbestos in Libby, Montana. The name of the registry is the Tremolite Asbestos Registry (TAR). Reproductive toxicity study is the only component of this PDN that is included in the EPA/ ATSDR test rule. 3B ......... 3C ........ 3D ........ 3E ......... 3F ......... 3G ........ Benzene ........................................ VerDate Aug<31>2005 20:13 Nov 28, 2005 4A ........ Jkt 208001 Dose-response data in animals for acute- and intermediate-duration oral exposure. The subchronic study should include an extended reproductive organ histopathology. PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 E:\FR\FM\29NON1.SGM 29NON1 71512 Federal Register / Vol. 70, No. 228 / Tuesday, November 29, 2005 / Notices TABLE 1.—ATSDR’S SUBSTANCE-SPECIFIC PRIORITY DATA NEEDS FOR 60 PRIORITY HAZARDOUS SUBSTANCES— Continued PDN ID 1 PDN description Program 2 Status change 3 Comments 4 4B ......... Prenatal developmental toxicity study via oral exposure. EPA ......... .................. Previously planned study in the MHPF Research Program to address this priority data need was canceled. 4C ........ Neurotoxicology battery of tests via oral exposure. Epidemiologic studies on the health effects of benzene (Special emphasis end points include immunotoxicity). EPA. .................. Filled ........ 4E ......... Substances Exposure levels in humans living near hazardous waste sites and other populations, such as exposed workers. .................. Filled ........ Based on an evaluation of the data in ATSDR’s 1997 updated toxicological profile. ATSDR will continue to evaluate new data as they become available to determine if additional studies are needed. Reference range concentrations are available (Ashley et al. 1992, 1994; Needham et al. 1995), and at least one ATSDR study that evaluated blood benzene levels and potential adverse health effects is available. ATSDR acknowledges that reference concentration data can support exposure and health assessments at waste sites, but the Agency also continues to recognize the importance of collecting additional data on uniquely exposed populations at waste sites. 5A ......... Dose-response data for acuteand intermediate-duration exposure via the oral route (the study of intermediate-duration exposure should include evaluation of reproductive and endocrine organ histopathology, lymphoid tissues histopathology as well as examination of relevant blood components, and nervous system histopathology). Exposure levels in humans living near hazardous waste sites. Exposure levels in children. Potential candidate for subregistry of exposed persons. Dose-response data in animals for acute- and intermediate-duration inhalation exposures. The subchronic study should include extended reproductive organ histopathology. Prenatal developmental toxicity study via inhalation exposure. Environmental fate in air; factors affecting bioavailability in air. Analytical methods to determine environmental speciation. 4D ........ Benzidine ...................................... 5B ......... 5C ........ 5D ........ Beryllium ....................................... 6A ......... 6B ......... 6C ........ 6D ........ 6E ......... VerDate Aug<31>2005 20:13 Nov 28, 2005 Jkt 208001 Immunotoxicology battery of tests following oral exposure. PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 ATSDR. EPA. EPA. EPA. .................. Filled ........ Based on an evaluation of the data in ATSDR’s 2000 updated toxicological profile. EPA. E:\FR\FM\29NON1.SGM 29NON1 71513 Federal Register / Vol. 70, No. 228 / Tuesday, November 29, 2005 / Notices TABLE 1.—ATSDR’S SUBSTANCE-SPECIFIC PRIORITY DATA NEEDS FOR 60 PRIORITY HAZARDOUS SUBSTANCES— Continued PDN ID 1 Program 2 Status change 3 Comments 4 Exposure levels in humans (adults) living near hazardous waste sites and other populations, such as exposed workers. .................. Filled ........ 6G ........ Exposure levels in children .......... .................. Filled ........ Reference range concentrations in urine are available (Paschal et al. 1998, CDC 2005). ATSDR acknowledges that reference concentration data can support exposure and health assessments at waste sites, but the Agency also continues to recognize the importance of collecting additional data on uniquely exposed populations at waste sites. Reference range concentrations in urine are available (CDC 2005). 6H ........ Potential candidate for subregistry of exposed persons. Analytical methods for biological tissues and fluids and environmental media. Exposure levels in humans (adults) living near hazardous waste sites and other populations, such as exposed workers. ATSDR. 7C ........ Cadmium ....................................... PDN description 6F ......... Substances Exposure levels in children .......... 8A ......... Dose-response data in animals for chronic oral exposure. The study should include extended reproductive organ and nervous tissue histopathology. Immunotoxicology battery of tests via oral exposure. 7A ......... 7B ......... Carbon tetrachloride ..................... 8B ......... .................. Filled ........ G. Lakes .. Filled ........ .................. Filled ........ NTP ......... Filled ........ 8C ........ .................. Filled ........ 8D ........ Exposure levels in humans living near hazardous waste sites and other populations, such as exposed workers. .................. Filled ........ 8E ......... Chlordane ..................................... Half-life in soil .............................. Potential candidate for subregistry of exposed persons. Oral multigenerational studies to evaluate reproductive toxicity. Bioavailability studies following ingestion of contaminated media. 20:13 Nov 28, 2005 NTP dose-finding study and one study in ATSDR’s 1994 updated toxicological profile addressed the priority data need. One study in ATSDR’s 1994 updated toxicological profile provided information on half-life in soil. Reference range concentrations in blood are available (Ashley et al. 1992, 1994; Needham et al. 1995). ATSDR acknowledges that reference concentration data can support exposure and health assessments at waste sites, but the Agency also continues to recognize the importance of collecting additional data on uniquely exposed populations at waste sites. ATSDR. 9A ......... 9B ......... VerDate Aug<31>2005 Based on an evaluation of the data in ATSDR’s 1999 updated toxicological profile. In addition to the data from the Great Lakes Research Program, reference range concentrations in blood and urine are available (CDC 2005), and at least nine ATSDR studies that evaluated blood and urine cadmium levels and potential adverse health effects are available. Reference range concentrations in blood and urine are available (CDC 2005). Jkt 208001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 MHPF ...... Filled ........ E:\FR\FM\29NON1.SGM Availability of studies in the MHPF Research Program. 29NON1 71514 Federal Register / Vol. 70, No. 228 / Tuesday, November 29, 2005 / Notices TABLE 1.—ATSDR’S SUBSTANCE-SPECIFIC PRIORITY DATA NEEDS FOR 60 PRIORITY HAZARDOUS SUBSTANCES— Continued PDN ID 1 Status change 3 Comments 4 Exposure levels in humans (adults) living near hazardous waste sites and other populations potentially exposed to chlordane. .................. Filled ........ Exposure levels in children .......... .................. Filled ........ Reference range concentrations in serum are available (CDC 2005). ATSDR acknowledges that reference concentration data can support exposure and health assessments at waste sites, but the Agency also continues to recognize the importance of collecting additional data on uniquely exposed populations at waste sites. Reference range concentrations in serum are available (CDC 2005). 9E ......... Potential candidate for subregistry of exposed persons. Studies via oral exposure designed to assess childhood susceptibility. Comparative toxicokinetic studies examining the relative absorption of CDDs across exposure routes and the relative contribution of each exposure route to total body burdens. Exposure levels in humans (adults) living near hazardous waste sites. ATSDR. .................. Filled ........ 10D ...... dibenzo-p-dioxins Program 2 9D ........ Chlorinated (CDDs). PDN description 9C ........ Substances Exposure levels in children .......... .................. Filled ........ 11A ....... Dose-response data in animals for acute- and intermediate-duration or exposures. The subchronic study should include an evaluation of immune and nervous system tissues, and extended reproductive organ histopathology. Dose-response data in animals for chronic inhalation exposure.s The study should include an evaluation of nervous system tissues. Potential candidate for subregistry of exposed persons. Dose-response data in animals for intermediate-duration oral exposure. Epidemiologic studies on the health effects of chloroform (Special emphasis end points include cancer, neurotoxicity, reproductive and developmental toxicity, hepatotoxicity, and renal toxicity). EPA. 10A ...... 10B ....... 10C ...... Chloroethane ................................ .............. 11C ...... Chloroform .................................... 12A ....... .............. VerDate Aug<31>2005 20:13 Nov 28, 2005 Jkt 208001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 Reference range concentrations in serum are available (CDC 2005). ATSDR acknowledges that reference concentration data can support exposure and health assessments at waste sites, but the Agency also continues to recognize the importance of collecting additional data on uniquely exposed populations at waste sites. Reference range concentrations in serum are available (CDC 2005). EPA. ATSDR. .................. Filled ........ .................. Filled ........ E:\FR\FM\29NON1.SGM An MRL was derived in ATSDR’s 1997 updated toxicological profile. Based on an evaluation of the data in ATSDR’s 1997 updated toxicological profile. ATSDR will continue to evaluate new data as they become available to determined if additional studies are needed. 29NON1 71515 Federal Register / Vol. 70, No. 228 / Tuesday, November 29, 2005 / Notices TABLE 1.—ATSDR’S SUBSTANCE-SPECIFIC PRIORITY DATA NEEDS FOR 60 PRIORITY HAZARDOUS SUBSTANCES— Continued PDN ID 1 Program 2 Status change 3 Comments 4 Exposure levels in humans living near hazardous waste sites and other populations, such as exposed workers. .................. Filled ........ Reference range concentrations in blood are available (Ashley et al. 1992, 1994; and Needham et al. 1995). ATSDR acknowledges that reference concentration data can support exposure and health assessments at waste sites, but the Agency also continues to recognize the importance of collecting additional data on uniquely exposed populations at waste sites. 12D ...... Chromium ..................................... PDN description 12C ...... Substances Potential candidate for subregistry of exposed persons. Dose-response data in animals for acute-duration exposure to chromium (VI) and (III) via oral exposure and for intermediateduration exposure to chromium (VI) via oral exposure. Multigeneration reproductive toxicity study via oral exposure to chromium (III) and (VI). Immunotoxicology battery of tests following oral exposure to chromium (III) and (VI). Prenatal 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. ATSDR. Filled ........ In addition to the data from the Great Lakes Research Program, reference range concentrations in urine are available (Paschal et al. 1998). Also, at least two STSDR studies that evaluated urine chromium levels and potential adverse health effects are available. Dose-response data in animals for acute- and intermediate-duration exposures via inhalation. The subchronic study should include extended reproductive organ histopathology and evaluation of neurobehavioral and neuropathological end points. Prenatal developmental toxicity study via oral exposure. Evaluation of the environmental fate of cyanide in soil. EPA. .................. Filled ........ A study addressing the priority data need was submitted by industry to EPA in response to EPA’s solicitation for proposals for test rule making. Scientists from EPA and ATSDR reviewed the study and considered that this research need is no longer a priority. .................. .................. 13A ...... 13B ....... 13C ...... 13D ...... 13E ....... Cynaide ......................................... 14A ....... 14B ....... 14C ...... 14D ...... 14E ....... 1,2-dibromo-3-chloropropane ....... VerDate Aug<31>2005 20:13 Nov 28, 2005 15A ...... Jkt 208001 Exposure levels in humans living near hazardous waste sites and other populations, such as exposed workers. Potential candidate for subregistry of exposed persons. Dose-response data in animals for acute-duration exposure via the oral route (including reproductive organ histopathology). PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 EPA. EPA. EPA. EPA. G. Lakes .. EPA. ATSDR. E:\FR\FM\29NON1.SGM 29NON1 71516 Federal Register / Vol. 70, No. 228 / Tuesday, November 29, 2005 / Notices TABLE 1.—ATSDR’S SUBSTANCE-SPECIFIC PRIORITY DATA NEEDS FOR 60 PRIORITY HAZARDOUS SUBSTANCES— Continued Program 2 PDN ID 1 PDN description 15B ....... Substances Dose-response data in animals for chronic-duration exposure via the oral route (including reproductive organ histopathology). Prenatal developmental toxicity study via oral exposure. Immunotoxicology testing battery via oral exposure. 15C ...... 15D ...... Comments 4 .................. .................. .................. .................. Previously planned study in the MHPF Research Program to address this priority data need was canceled. Previously planned study in the MHPF Research Program to address this priority data need was canceled. 15E ....... Neurotoxicology testing via oral exposure. 15G ...... 1,2-Dibromoethane ....................... Potential candidate for subreg- ATSDR. istry of exposed persons. Dose-response data in animals for acute- and intermediate-duration exposure by the oral route (the study of intermediate-duration exposure should include evaluation of neuropathology and observation for overt signs of neurotoxicity). Multigeneration reproductive toxicity studies via oral exposure. Developmental toxicity studies via oral exposure. Immunotoxicity battery studies via oral exposure. Exposure levels in humans living near hazardous waste sites and in other populations, such as workers exposed to 1, 2dibromoethane. Exposure levels in children. Potential candidate for subreg- ATSDR. istry of exposed persons. Dose-response data in animals for acute-duration (14-day) exposure by the inhalation route, including a comparison of young and adult animals. Dose-response data in animals for acute-duration (14-day) exposure by the oral route, including a comparison of young and adult animals. Dose-response data in animals for intermediate-duration exposure by the inhalation route (the study should be performed in conjunction with the neurotoxicology battery of tests). Neurotoxicology battery of tests following inhalation exposure. Neurotoxicology battery of tests following oral exposure. Dose-response data in animals for chronic-duration exposure by the oral route. Prenatal developmental toxicity data for inhalation exposure (assessment of developmental cardiotoxicity and neurotoxicity). 16A ...... 16B ....... 16C ...... 16D ...... 16E ....... 16F ....... 16G ...... 1,2-Dichloroethane ........................ 17A ....... 17B ....... 17C ...... 17D ...... 17E ....... 17F ....... 17G ...... VerDate Aug<31>2005 20:13 Nov 28, 2005 Jkt 208001 PO 00000 Frm 00058 Fmt 4703 battery Status change 3 Sfmt 4703 E:\FR\FM\29NON1.SGM 29NON1 71517 Federal Register / Vol. 70, No. 228 / Tuesday, November 29, 2005 / Notices TABLE 1.—ATSDR’S SUBSTANCE-SPECIFIC PRIORITY DATA NEEDS FOR 60 PRIORITY HAZARDOUS SUBSTANCES— Continued PDN ID 1 PDN description 17H ...... Substances Prenatal developmental toxicity data for oral exposure (assessment of developmental cardiotoxicity and neurotoxicity). Additional analyses and studies for comparative toxicokinetics across species, ages, routes, and durations ≤. Children’s susceptibility. Exposure levels in humans living near hazardous waste sites. Exposure levels in children. Potential candidate for subregistry of exposed persons. Dose-response data in animals for acute-duration exposure by the inhalation route. Dose-response data in animals for chronic-duration exposure by the inhalation route. Dose-response data in animals for acute- and intermediate-duration exposure by the oral route. Carcinogenicity studies in two species following inhalation exposure. Reproductive toxicity studies assessing male and female end points following inhalation exposure. Prenatal developmental toxicity studies following oral exposure. Immunotoxicology battery of tests following oral exposure. Battery of neurobehavioral tests following inhalation exposure. Children’s susceptibility. Exposure levels in humans living near hazardous waste sites. Exposure levels in children. Potential candidate for subregistry of exposed persons. Dose-response data in animals for chronic-duration oral exposure. Comparative toxicokinetic study (across routes/species). Bioavailability and bioaccumulation from soil. Epidemiologic studies on the health of DDT, DDD, and DDE (Special emphasis end points include immunotoxicity, and reproductive and developmental toxicity). 17I ........ 17J ....... 17K ....... 17L ....... 17M ...... 1,1-Dichloroethene ........................ 18A ....... 18B ....... 18C ...... 18D ...... 18E ....... 18F ....... 18G ...... 18H ...... 18I ........ 18J ....... 18K ....... 18L ....... DDT ............................................... 19A ....... 19B ....... 19C ...... 19D ...... VerDate Aug<31>2005 20:13 Nov 28, 2005 Jkt 208001 PO 00000 Frm 00059 Fmt 4703 Status change 3 Comments 4 NTP ......... Filled ........ Availability of ongoing NTP study. NTP ......... Filled ........ Availability of ongoing NTP study. Filled ........ In addition to the data from the Great Lakes Research Program, multiple studies in ATSDR’s 2000 updated toxicological profile are available. Program 2 Sfmt 4703 ATSDR. ATSDR. G. Lakes .. E:\FR\FM\29NON1.SGM 29NON1 71518 Federal Register / Vol. 70, No. 228 / Tuesday, November 29, 2005 / Notices TABLE 1.—ATSDR’S SUBSTANCE-SPECIFIC PRIORITY DATA NEEDS FOR 60 PRIORITY HAZARDOUS SUBSTANCES— Continued PDN ID 1 Program 2 Status change 3 Comments 4 Exposure levels in humans (adults) living near hazardous waste sites and other populations, such as exposed workers. G. Lakes .. Filled ........ 19F ....... Exposure levels in children .......... .................. Filled ........ In addition to the data from the Great Lakes Research Program, reference range concentrations in serum are available (CDC 2005). ATSDR acknowledges that reference concentration data can support exposure and health assessments at waste sites, but the Agency also continues to recognize the importance of collecting additional data on uniquely exposed populations at waste sites. Reference range concentrations in serum are available (CDC 2005). 19G ...... Potential candidate for subregistry of exposed persons. Epidemiologic studies on the health effects of DEHP (Special emphasis end points include cancer). Dose-response data in animals for acute- and intermediate-duration oral exposures. The subchronic study should include an extended histopathologic evaluation of the immunologic and neurologic systems. ATSDR. 20B ....... .................. .................. 20C ...... Multigeneration reproductive toxicity study via oral exposure. .................. .................. 20D ...... Di (2-ethylhexyl) phthalate ............ PDN description 19E ....... Substances Comparative toxicokinetic studies (Studies designed to examine how primates metabolize and distribute DEHP as compared with rodents via oral exposure). Exposure levels in humans living near hazardous waste sites and other populations, such as exposed workers. Potential candidate for subregistry of exposed persons.. Dose-response data in animals for acute-duration exposure via the oral route. Dose-response data in animals for chronic-duration exposure via the oral route. Carcinogenicity studies via oral exposure. .................. Filled ........ 20A ....... 20E ....... 20F ....... Di-n-butyl phtalate ......................... 21A ...... 21B ....... 21C ...... VerDate Aug<31>2005 20:13 Nov 28, 2005 Jkt 208001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 This research need remains as a priority data need because the previously developed MRL for acute-duration (1993 toxicological profile) was withdrawn. However, a new MRL for intermediate-duration was derived in ATSDR’s 2002 updated Toxicological Profile. Therefore, this priority data need is considered partially filled because additional adequate acute-duration data for deriving an MRL are still lacking. This research need is reassigned as a priority data need based on an evaluation of the data in ATSDR’s 2002 updated toxicological profile. Also, the NTP Center for the Evaluation of Risks to Human Reproduction Expert Panel Report (October 2000) has identified critical data needs for reproductive toxicity. The existing database provides adequate information to fill this priority data need based on ATSDR’s reevaluation of the published data. ATSDR. NTP ......... Filled ........ E:\FR\FM\29NON1.SGM Availability of an NTP study. 29NON1 71519 Federal Register / Vol. 70, No. 228 / Tuesday, November 29, 2005 / Notices TABLE 1.—ATSDR’S SUBSTANCE-SPECIFIC PRIORITY DATA NEEDS FOR 60 PRIORITY HAZARDOUS SUBSTANCES— Continued PDN ID 1 PDN description Program 2 Status change 3 Comments 4 21D ...... In vivo genotoxicity studies .......... MHPF ...... Filled ........ Availability of a study in the MHPF Research Program 21E ....... Substances Exposure levels in humans living near hazardous waste sites and other populations, such as exposed workers. Environmental fate of di-n-butyl phthalate in environmental media. Bioavailability in contaminated environmental media near hazardous waste sites. Potential candidate for subregistry of exposed persons.. Immunotoxicology testing battery following oral exposure. Exposure levels of disulfoton in tissues/fluids for populations living near hazardous waste sites and other populations, such as exposed workers. Disulfoton should be considered as a potential candidate for a subregistry of exposed persons. Acute-duration oral exposure studies. Data on sensitive neurologic end point following oral exposure. Exposure levels in humans living near hazardous waste sites and other populations, such as exposed workers. Data on the bioavailability of endosulfan from soil. Potential candidate for subregistry of exposed persons. Dose-response animal data for acute oral exposure to endrin. Multigeneration reproductive toxicity studies via oral exposure to endrin. Accurately describe the toxicokinetics of endrin and its degradation products and identify the animal species to be used as the most appropriate model for human exposure. Exposure levels for endrin and its degradation products in humans living near hazardous waste sites. Accurately describe the environmental fate of endrin, including environmental breakdown products and rates, media halflives, and chemical and physical properties of the breakdown products that help predict mobility and volatility. Potential candidate for subregistry of exposed persons. Dose-response data for acute-duration exposure by the inhalation route. Dose-response data for chronicduration exposure by the inhalation route. Filled ........ Availability of ongoing NTP study. 21F ....... 21G ...... 21H ...... Disulfoton ...................................... 22A ...... 22B ....... 22C ...... Endosulfan (a, b, and sulfate) ...... 23A ...... 23B ....... 23C ...... 23D ...... 23E ....... Endrin/endrin aldehyde ................. 24A ....... 24B ....... 24C ...... 24D ...... 24E ....... 24F ....... Ethylbenzene ................................ 25A ...... 25B ....... VerDate Aug<31>2005 20:13 Nov 28, 2005 Jkt 208001 PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 ATSDR. NTP ......... ATSDR. ATSDR. ATSDR. E:\FR\FM\29NON1.SGM 29NON1 71520 Federal Register / Vol. 70, No. 228 / Tuesday, November 29, 2005 / Notices TABLE 1.—ATSDR’S SUBSTANCE-SPECIFIC PRIORITY DATA NEEDS FOR 60 PRIORITY HAZARDOUS SUBSTANCES— Continued PDN ID 1 PDN description 25C ...... Substances Dose-response data for acuteand intermediate-duration exposure by the oral route; the study of intermediate-duration exposure should include an evaluation of clinical signs of neurotoxicity and histopathology of reproductive organs, endocrine glands, and nervous system. Multigeneration toxicity study examining reproductive end points and indicators of endocrine disruption following inhalation exposure. Prenatal developmental study with continued assessment of offspring during postnatal development following oral exposure. Studies for comparative toxicokinetics. Exposure levels in humans living near hazardous waste sites. Exposure levels in children. Potential candidate for subregistry of exposed persons. Dose-response animal data for acute- and intermediate-duration oral exposures, including immunopathology. Multigeneration reproductive toxicity studies via the oral route of exposure. 25D ...... 25E ....... 25F ....... 25G ...... 25H ...... 25I ........ Heptachlor/heptachlor epoxide ..... 26A ...... 26B ....... Status change 3 Comments 4 NTP ......... Filled ........ Availability of publication ‘‘The effects of perinatal/juvenile heptachlor exposure on adult immune and reproductive system function in rats’’ by Smialowicz et al. (2001), Toxicological Sciences 61:164–175. Based on ATSDR’s review of the literature, i.e., Smialowicz et al. (2001), Toxicological Sciences 61:164–175 and Moser et al. (2001) Toxicological Sciences 60 (2):315–326. Reference range concentrations in serum are available (CDC 2005). ATSDR acknowledges that reference concentration data can support exposure and health assessments at waste sites, but the Agency also continues to recognize the importance of collecting additional data on uniquely exposed populations at waste sites. Reference range concentrations in serum are available (CDC 2005). Program 2 ATSDR. 26C ...... Prenatal developmental toxicity studies via the oral route of exposure. .................. Filled ........ 26D ...... Exposure levels in humans (adults) living near hazardous waste sites and other populations, such as exposed workers. .................. Filled ........ 26E ....... Exposure levels in children .......... .................. Filled ........ 26F ....... Bioavailability from contaminated air, water, and soil and bioaccumulation potential. Potential candidate for subregistry of exposed persons. Dose-response data in animals for acute-duration exposure via the oral route. ATSDR. 26G ...... Hexachlorobutadiene .................... VerDate Aug<31>2005 20:13 Nov 28, 2005 27A ...... Jkt 208001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 E:\FR\FM\29NON1.SGM 29NON1 71521 Federal Register / Vol. 70, No. 228 / Tuesday, November 29, 2005 / Notices TABLE 1.—ATSDR’S SUBSTANCE-SPECIFIC PRIORITY DATA NEEDS FOR 60 PRIORITY HAZARDOUS SUBSTANCES— Continued Status change 3 Comments 4 .................. Filled ........ An MRL was derived in ATSDR’s 1999 updated toxicological profile. 28C ...... Mechanistic studies on the neurotoxicity, hepatotoxicity, reproductive toxicity, and immunotoxicity of hexachlorocyclohexane. Exposure levels in humans (adults) living near hazardous waste sites and other populations, such as exposed workers. .................. Filled ........ 28D ...... Exposure levels in children .......... .................. Filled ........ Reference range concentrations in serum are available (CDC 2005). ATSDR acknowledges that reference concentration data can support exposure and health assessments at waste sites, but the Agency also continues to recognize the importance of collecting additional data on uniquely exposed populations at waste sites. Reference range concentrations in serum are available (CDC 2005). 28E ....... ATSDR. 29A ...... Potential candidate for subregistry of exposed persons. Mechanistic studies on the neurotoxic effects of lead. MHPF ...... Filled ........ 29B ....... Analytical methods for tissue levels. MHPF ...... Filled ........ 29C ...... Exposure levels in humans (adults) near hazardous waste sites and other populations, such as exposed workers. MHPF, G. Lakes. Filled ........ 29D ...... Exposure levels in children .......... .................. Filled ........ PDN ID 1 PDN description 27B ....... Substances Exposure levels in humans living near hazardous waste sites and other populations, such as exposed workers. Environmental fate studies that determine the extent to which hexachlorobutadiene volatilizes from soil, and studies that determine the reactions and rates which drive degradation in soil. Bioavailability studies in soil and plants. Potential candidate for subregistry of exposed persons. Dose-response data for chronicduration oral exposure. 27C ...... 27D ...... 27E ....... Hexachlorocyclohexane (a, b and g). 28A ...... 28B ....... Lead .............................................. VerDate Aug<31>2005 20:13 Nov 28, 2005 Jkt 208001 PO 00000 Frm 00063 Fmt 4703 Program 2 Sfmt 4703 ATSDR. E:\FR\FM\29NON1.SGM Multiple studies (at least 13 publications from the MHPF Research Program + numerous studies in ATSDR’s 1999 updated toxicological profile) are available. A publication from the MHPF Research Program and numerous studies in ATSDR’s 1999 toxicological profile are available. In addition to the data from Great Lakes Research Program and MHPF Research Program, reference range concentrations in blood and urine are available (CDC 2005; Paschal et al. 1998), and at least 19 ATSDR studies that evaluated blood lead levels and potential adverse health effects are available. Reference range concentrations in blood and urine are available (CDC 2005). 29NON1 71522 Federal Register / Vol. 70, No. 228 / Tuesday, November 29, 2005 / Notices TABLE 1.—ATSDR’S SUBSTANCE-SPECIFIC PRIORITY DATA NEEDS FOR 60 PRIORITY HAZARDOUS SUBSTANCES— Continued Substances PDN ID 1 PDN description Manganese ................................... 30A ....... Dose-response data for acuteand intermediate-duration oral exposures (the subchronic study should include reproductive histopathology and an evaluation of immunologic parameters including manganese effects on plaque-forming cells (SRBC), surface markers (D4:D8 ratio), and delayed hypersensitivity reactions). Toxicokinetic studies on animals to investigate uptake and absorption, relative uptake of differing manganese compounds, metabolism of manganese, and interaction of manganese with other substances following oral exposure. Epidemiological studies on the health effects of manganese (Special emphasis end points include neurologic, reproductive, developmental, immunologic, and cancer). 30B ....... 30C ...... 30D ...... 30E ....... Mercury ......................................... 31A ...... 31B ....... 31C ...... 31D ...... Status change 3 Comments 4 MHPF, EPA. Filled ........ Availability of studies in the MHPF Research Program. MHPF, EPA. Filled ........ Availability of studies in the MHPF Research Program. .................. Filled ........ Based on an evaluation of the data in ATSDR’s 2000 updated toxicological profile. ATSDR will continue to evaluate new data as they become available to determine if additional studies are needed. MHPF ...... Filled ........ .................. Filled ........ Availability of publications from the MHPF Research Program. An MRL was derived in ATSDR’s 1999 updated toxicological profile. Program 2 Exposure levels in humans living near hazardous waste sites and other populations, such as exposed workers. Relative bioavailability of different manganese compounds and bioavailability of manganese from soil. Multigeneration reproductive toxicity study via oral exposure. Dose-response data in animals from chronic-duration oral exposure. Immunotoxicology battery of tests via oral exposure. Exposure levels in humans (adults) living near hazardous waste sites and other populations, such as exposed workers. EPA. EPA. G. Lakes .. Filled ........ Filled ........ 31E ....... .................. 31F ....... Methoxychlor ................................. Exposure levels in children .......... Potential candidate for subregistry of exposed persons. Evaluate neurologic effects after long-term, low-level oral exposure. Exposure levels of methoxychlor and primary metabolites in humans living near hazardous waste sites and those individuals with the potential to ingest it.. ATSDR. 32A ...... 32B ....... VerDate Aug<31>2005 20:13 Nov 28, 2005 In addition to the data from the Great Lakes Research Program, background levels data are available in ATSDR’s 1997 updated toxicological profile, and multiple ATSDR studies that evaluated blood, urine, hair mercury levels and potential adverse health effects are available. Also, reference range concentrations in blood and urine are available (CDC 2005). Reference range concentrations in blood and urine are available (CDC 2005). Jkt 208001 PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 .................. Filled ........ E:\FR\FM\29NON1.SGM Based on an evaluation of the data in ATSDR’s 2000 updated toxicological profile. 29NON1 71523 Federal Register / Vol. 70, No. 228 / Tuesday, November 29, 2005 / Notices TABLE 1.—ATSDR’S SUBSTANCE-SPECIFIC PRIORITY DATA NEEDS FOR 60 PRIORITY HAZARDOUS SUBSTANCES— Continued Status change 3 Comments 4 EPA, Vol Res. Filled ........ Prenatal developmental toxicity study via the oral route. Exposure levels in humans living near hazardous waste sites and other populations, such as exposed workers. Vol Res .... Filled ........ .................. Filled ........ ATSDR accepted HSIA’s toxicity study for acute- and intermediate-duration exposure duration in February 1997. Also, ATSDR accepted HSIA’s immunotoxicity study via inhalation in November 2000 and the oral data obtained via PBPK modeling conducted by HSIA based on the immunotoxicity data from the inhalation study. Neurotoxicity screening battery testing remains in the ATSDR/EPA test rule under development. ATSDR accepted HSIA’s study in February 1997. Reference range concentrations in blood are available (Ashley et al. 1992, 1994; Needham et al. 1995). ATSDR acknowledges that reference concentration data can support exposure and health assessments at waste sites, but the Agency also continues to recognize the importance of collecting additional data on uniquely exposed populations at waste sites. ATSDR. 34A ...... Potential candidate for subregistry of exposed persons. Epidemilogic studies on the health effects of nickel (Special emphasis end points include reproductive toxicity). .................. Filled ........ 34B ....... Prenatal development toxicity study via the oral route. EPA ......... Filled ........ 34C ...... Dose-response data in animals for acute- and intermediate-duration oral exposures. Neurotoxicology battery of tests via oral exposure. Bioavailability of nickel from soil .. Exposure levels in humans (adults) living near hazardous waste sites and other populations, such as exposed workers. Potential candidate for subregistry of exposed persons. Comparative toxicokinetic studies.. EPA. PDN ID 1 PDN description 32C ...... Substances Evaluate the fate, transport, and levels of the degradation products of methoxychlor in soil.. Potential candidate for subregistry of exposed persons. Dose-response data in animals for acute- and intermediate-duration oral exposure. The subchronic study should include extended reproductive organ histopathology, neuropathology, and immunopathology. 32D ...... Methylene chloride ........................ 33A ...... 33B ....... 33C ...... 33D ...... Nickel ............................................ 34D ...... 34E ....... 34F ....... 34G ...... Pentachlorophenol ........................ VerDate Aug<31>2005 20:13 Nov 28, 2005 35A ....... Jkt 208001 PO 00000 Frm 00065 Fmt 4703 Program 2 Sfmt 4703 ATSDR. Based on at least two relevant studies in ATSDR’s 1997 updated toxicological profile. ATSDR will continue to evaluate new data as they become available to determine if additional studies are needed. In ATSDR’s 1997 updated toxicological profile, a study confirming the results of two previous studies is available. EPA. EPA. G. Lakes .. Filled ........ Based on availability of the data from the Great Lakes Research Program and an evaluation of ATSDR’s 1997 updated toxicological profile. ATSDR. E:\FR\FM\29NON1.SGM 29NON1 71524 Federal Register / Vol. 70, No. 228 / Tuesday, November 29, 2005 / Notices TABLE 1.—ATSDR’S SUBSTANCE-SPECIFIC PRIORITY DATA NEEDS FOR 60 PRIORITY HAZARDOUS SUBSTANCES— Continued PDN ID 1 Program 2 Status change 3 Comments 4 Exposure levels in humans (adults) living near hazardous waste sites. .................. Filled ........ 35C ...... Exposure levels in children .......... .................. Filled ........ Reference range concentrations in urine are available (CDC 2005. ATSDR acknowledges that reference concentration data can support exposure and health assessments at waste sites, but the Agency also continues to recognize the importance of collecting additional data on uniquely exposed populations at waste sites. Reference range concentrations in urine are available (CDC 2005). 35D ...... Polychlorinated biphenyls (PCBs) PDN description 35B ....... Substances Potential candidate for subregistry of exposed persons. Dose-response data in animals for acute- and intermediate-duration oral exposure. ATSDR. 36A ....... 36B ....... 36C ...... 36D ...... 36E ....... Biodegradation of PCBs in water; bioavailability of PCBs in air, water, and soil.. Dose-response data in animals for acute- and intermediate-duration inhalation exposures. The subchronic study should include extended reproductive organ histopathology.. Epidemiologic studies on the health effects of PCBs (Special emphasis end points include immunotoxicity, gastrointestinal toxicity, liver toxicity, kidney toxicity, thyroid toxicity, and reproductive/developmental toxicity). Exposure levels in humans (adults) living near hazardous waste sites and other populations, such as exposed workers. G. Lakes .. .................. Although an MRL for intermediate-exposure duration was derived in ATSDR’s 2000 updated toxicological profile, an MRL for acute-exposure duration is still lacking. G. Lakes .. Filled ........ In addition to the data from the Great Lakes Research Program, multiple studies in ATSDR’s 2000 updated toxicological profile are available. G. Lakes .. Filled ........ Filled ........ In addition to the data from the Great Lakes Research Program, background levels data are available (ATSDR’s 1997 updated toxicological profile, Needham et al. 1996, and CDC 2005). Also, multiple ATSDR studies that evaluated blood and breast milk PCB levels and potential adverse health effects are available. Reference range concentrations in serum are available (CDC 2005). 36F ....... Exposure levels in children .......... .................. 36G ...... Potential candidate for subregistry of exposed persons. Chronic toxicity and oncogenicity via oral exposure. ATSDR. 36H5 ..... 36I5 ...... 36J5 ...... VerDate Aug<31>2005 20:13 Nov 28, 2005 Jkt 208001 Aerobic PCB biodegradation in sediment. PCB congener analysis ............... PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 Vol Res .... Filled ........ Vol Res .... Filled ........ Vol Res, Filled ........ G. Lakes. E:\FR\FM\29NON1.SGM ATSDR accepted the final report of the GE study in October 1997. ATSDR accepted the final report of the GE study in July 1999. ATSDR accepted the final report of the GE study in October 1997. Also, data from the Great Lakes Research Program are available. 29NON1 71525 Federal Register / Vol. 70, No. 228 / Tuesday, November 29, 2005 / Notices TABLE 1.—ATSDR’S SUBSTANCE-SPECIFIC PRIORITY DATA NEEDS FOR 60 PRIORITY HAZARDOUS SUBSTANCES— Continued Substances PDN ID 1 PDN description Program 2 Status change 3 Comments 4 Polycyclic aromatic hydrocarbons (PAHs) (Includes 15 substances). 37A ...... Dose-response data in animals for intermediate-duration oral exposures. The subchronic study should include extended reproductive organ histopathology and immunopathology. Prenatal developmental toxicity study via inhalation or oral exposure. Mechanistic studies on PAHs, on how mixtures of PAHs can influence the ultimate activation of PAHs, and on how PAHs affect rapidly proliferating tissues.. Dose-response data in animals for acute- and intermediate-duration inhalation exposures. The subchronic study should include extended reproductive organ histopathology and immunopathology. Epidemiologic studies on the health effects of PAHs (Special emphasis end points include cancer, dermal, hemolymphatic, and hepatic toxicity). MHPF ...... Filled ........ MRLs for four PAHs were derived in ATSDR’s 1995 updated toxicological profile. A publication from the MHPF Research Program addressing this priority data need is available. MHPF ...... Filled ........ MHPF ...... Filled ........ MHPF ...... Filled ........ Data from the MHPF Research Program including a publication are available. In addition to publications from the MHPF Research Program, studies are available in ATSDR’s 1995 updated toxicological profile. Data from the MHPF Research Program including one publication are available. .................. Filled ........ 37B ....... 37C ...... 37D ...... 37E ....... 37F ....... G. Lakes .. Filled ........ 37G ...... Exposure levels in children .......... .................. Filled ........ 37H ...... Selenium ....................................... Exposure levels in humans (adults) living near hazardous waste sites and other populations, such as exposed workers. Potential candidate for subregistry of exposed persons. Dose-response data in animals for EPA acute-duration oral exposure. Immunotoxicology battery of tests via oral exposure. Epidemiologic studies on the health effects of selenium (Special emphasis end points include cancer, reproductive and developmental toxicity, hepatotoxicity, and adverse skin effects). ATSDR. 38A ....... 38B ....... 38C ...... VerDate Aug<31>2005 20:13 Nov 28, 2005 Multiple studies in ATSDR’s 1995 updated toxicological profile are available. ATSDR will continue to evaluate new data as they become available to determine if additional studies are needed. Based on data from the Great Lakes Research Program and an evaluation of the ATSDR 1995 updated toxicological profile. Also, reference range concentrations in urine are available (CDC 2005). The Agency continues to recognize the importance of collecting additional data on uniquely exposed populations at waste sites. Reference range concentrations in urine are available (CDC 2005). Jkt 208001 PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 EPA. EPA. .................. Filled ........ E:\FR\FM\29NON1.SGM Based on an evaluation of ATSDR’s 2001 updated toxicological profile. ATSDR will continue to evaluate new data as they become available to determine if additional studies are needed. 29NON1 71526 Federal Register / Vol. 70, No. 228 / Tuesday, November 29, 2005 / Notices TABLE 1.—ATSDR’S SUBSTANCE-SPECIFIC PRIORITY DATA NEEDS FOR 60 PRIORITY HAZARDOUS SUBSTANCES— Continued PDN ID 1 Program 2 Status change 3 Comments 4 Exposure levels in humans living near hazardous waste sites and other populations, such as exposed workers. G. Lakes .. Filled ........ In addition to the data from the Great Lakes Research Program, reference range concentrations in serum are available (NHANES III). ATSDR acknowledges that reference concentration data can support exposure and health assessments at waste sites, but the Agency also continues to recognize the importance of collecting additional data on uniquely exposed populations at waste sites. 38E ....... Potential candidate for subregistry of exposed persons. Prenatal developmental toxicity study by the oral route. Immunotoxicity battery following oral exposure. Mammalian in vivo genotoxicity assays. Exposure levels in humans living near hazardous waste sites. Exposure levels in children. Potential candidate for subregistry of exposed persons. Dose-response data in animals for acute-duration oral exposure, including neuropathology and demeanor, and immunopathology. Multigeneration reproductive toxicity study via oral exposure. ATSDR. .................. Filled ........ An MRL was derived in the ATSDR 1997 updated toxicological profile. Vol Res .... .................. 40C ...... Dose-response data in animals for intermediate-duration oral exposure, including neuropathology, and immunopathology. EPA, Vol Res. .................. 40D ...... Prenatal developmental toxicity study via oral exposure. Vol Res .... .................. HSIA’s inhalation study was accepted by ATSDR and included in ATSDR’s 1997 updated toxicological profile. However, ATSDR has identified ingestion of contaminated environmental media to be the primary exposure route for this chemical at waste sites. HSIA will obtain the oral data from the inhalation study by conducting PBPK modeling. HSIA will obtain oral data for intermediate-duration toxicity and neurotoxicity by PBPK modeling based on existing inhalation data. Also, it will conduct an inhalation immunotoxicity study, followed by PBPK modeling to obtain oral data. HSIA’s developmental toxicity study via inhalation was accepted by ATSDR. However, ATSDR has identified ingestion of contaminated environmental media to be the primary exposure route for this chemical at waste sites. HSIA will obtain the oral data from the inhalation study by conducting PBPK modeling. 40E ....... 1,1,2,2-Tetrachloroethane ............. PDN description 38D ...... Substances Developmental neurotoxicity study via oral exposure. EPA, Vol Res. 39A ...... 39B ....... 39C ...... 39D ...... 39E ....... 39F ....... Tetrachloroethylene ...................... 40A ...... 40B ....... VerDate Aug<31>2005 20:13 Nov 28, 2005 Jkt 208001 PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 ATSDR. E:\FR\FM\29NON1.SGM 29NON1 71527 Federal Register / Vol. 70, No. 228 / Tuesday, November 29, 2005 / Notices TABLE 1.—ATSDR’S SUBSTANCE-SPECIFIC PRIORITY DATA NEEDS FOR 60 PRIORITY HAZARDOUS SUBSTANCES— Continued PDN ID 1 Program 2 Status change 3 Comments 4 Exposure levels in humans living near hazardous waste sites and other populations, such as exposed workers. .................. Filled ........ Reference range concentrations in blood are available (Ashley et al. 1992, 1994; Needham et al. 1995). ATSDR acknowledges that reference concentration data can support exposure and health assessments at waste sites, but the Agency also continues to recognize the importance of collecting additional data on uniquely exposed populations at waste sites. 40G ...... Potential candidate for subregistry of exposed persons. Dose-response data in animals for acute- and intermediate-duration oral exposures. The subchronic study should include an extended histopathologic evaluation of the immune system. Comparative toxicokinetic studies (Characterization of absorption, distribution, and excretion via oral exposure). Neurotoxicology battery of tests via oral exposure. ATSDR. .................. Filled ........ Availability of MRLs for acuteand intermediate- exposure durations in ATSDR’s 2000 updated toxicological profile. .................. Filled ........ Based on evaluation of the data in ATSDR’s 2000 updated toxicological profile. EPA, MHPF. .................. 41D ...... Mechanism of neurotoxicity. toluene-induced .................. Filled ........ 41E ....... Exposure levels in humans living near hazardous waste sites and other populations, such as exposed workers. .................. Filled ........ A publication for acute exposure but not longer term exposure is available in the MHPF Research Program. Also, this priority data need is included in the EPA/ATSDR test rule. Multiple studies in ATSDR’s 1994 and 2000 updated toxicological profiles are available. Reference range concentrations in blood are available (Ashley et al. 1992, 1994; Needham et al. 1995), and additional data in ATSDR’s 2000 updated toxicological profile are available. ATSDR acknowledges that reference concentration data can support exposure and health assessments at waste sites, but the Agency also continues to recognize the importance of collecting additional data on uniquely exposed populations at waste sites. 41F ....... Toluene ......................................... PDN description 40F ....... Substances Potential candidate for subregistry of exposed persons. Identify the long-term health consequences of exposure to environmental toxaphene via oral exposure. Conduct additional immunotoxicity studies for chronic-duration via oral route of exposure. Conduct additional neurotoxicity studies for chronic-duration via oral route of exposure. Exposure levels in humans living in areas near hazardous waste sites with toxaphene and in those individuals with the potential to ingest it. Potential candidate for subregistry of exposed persons. ATSDR. 41A ....... 41B ....... 41C ...... Toxaphene .................................... 42A ....... 42B ....... 42C ...... 42D ...... 42E ....... VerDate Aug<31>2005 20:13 Nov 28, 2005 Jkt 208001 PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 ATSDR. E:\FR\FM\29NON1.SGM 29NON1 71528 Federal Register / Vol. 70, No. 228 / Tuesday, November 29, 2005 / Notices TABLE 1.—ATSDR’S SUBSTANCE-SPECIFIC PRIORITY DATA NEEDS FOR 60 PRIORITY HAZARDOUS SUBSTANCES— Continued Substances PDN ID 1 PDN description Program 2 Status change 3 Comments 4 Trichloroethylene .......................... 43A ...... Dose-response data in animals for acute-duration oral exposure. Neurotoxicology battery of tests via the oral route. .................. Filled ........ EPA, MHPF, Vol Res. .................. An MRL was derived in ATSDR’s 1997 updated toxicological profile. A publication for acute exposure but not longer term exposure is available in the MHPF Research Program. Also, this priority data need is included in the EPA/ATSDR test rule and ATSDR’s Voluntary Research Program. HSIA has completed an inhalation immunotoxicity study which is undergoing ATSDR peer review. HSIA will obtain oral data via PBPK modeling based on the inhalation data. ATSDR has accepted HSIA’s final report for an inhalation developmental toxicity study. HSIA will use PBPK modeling to obtain data for oral exposure based on the results of its inhalation study. 43B ....... 43C ...... Immunotoxicology battery of tests via oral route. Vol Res .... .................. 43D ...... Prenatal developmental toxicity study via oral exposure. Vol Res .... .................. 43E ....... Developmental neurotoxicity study via oral exposure. Epidemiologic studies on the health effects of trichloroethylene (Special emphasis end points include cancer, hepatotoxicity, renal toxicity, developmental toxicity, and neurotoxicity). Exposure levels in humans living near hazardous waste sites and other populations, such as exposed workers. EPA, Vol Res. .................. Filled ........ .................. Filled ........ Dose-response data in animals for acute-duration inhalation exposure. Multigeneration reproductive toxicity study via inhalation. .................. Filled ........ Vol Res .... Filled ........ Vol Res .... Filled ........ 43F ....... 43G ...... Vinyl chloride ................................ 44A ...... 44B ....... 44C ...... 44D ...... 44E ....... 44F ....... 44G ...... VerDate Aug<31>2005 20:13 Nov 28, 2005 Jkt 208001 Dose-response data in animals for chronic-duration inhalation exposure.. Mitigation of vinyl chloride-induced toxicity. Prenatal developmental toxicity study via inhalation. Exposure levels in humans living near hazardous waste sites and other populations, such as exposed workers.. Potential candidate for subregistry of exposed persons. PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 Based on evaluation of the data in ATSDR’s 1997 updated toxicological profile. ATSDR will continue to evaluate new data as they become available to determine if additional studies are needed. Reference range concentrations in blood are available (Ashley et al. 1992, 1994; Needham et al. 1995). ATSDR acknowledges that reference concentration data can support exposure and health assessments at waste sites, but the Agency also continues to recognize the importance of collecting additional data on uniquely exposed populations at waste sites. An MRL was derived in ATSDR’s 1997 updated toxicological profile. ATSDR accepted the final report of ACC’s study in November 2000. ATSDR accepted the final report of ACC’s study in November 2000. ATSDR. E:\FR\FM\29NON1.SGM 29NON1 71529 Federal Register / Vol. 70, No. 228 / Tuesday, November 29, 2005 / Notices TABLE 1.—ATSDR’S SUBSTANCE-SPECIFIC PRIORITY DATA NEEDS FOR 60 PRIORITY HAZARDOUS SUBSTANCES— Continued Status change 3 Comments 4 MHPF ...... Filled ........ Availability of ongoing studies in the MHPF Research Program. MHPF ...... Filled ........ Availability of ongoing studies in the MHPF Research Program. .................. .................. This priority data need, previously anticipated to be addressed under the voluntary research program, is not being investigated under any of the ATSDR research programs. Substances PDN ID 1 PDN description Xylenes ......................................... 45A ...... Dose-response data for chronicduration exposure by the oral route. This study should be done in conjunction with the neurotoxicology battery of tests. Neurotoxicology battery of tests following oral exposure.. Two-generation reproductive study following oral exposure.. Developmental toxicity study that includes neurodevelopmental end points following oral exposure.. Exposure levels in humans living near hazardous waste sites.. Exposure levels in children.. Potential candidate for subregistry of exposed persons. Dose-response data in animals for acute- and intermediate-duration oral exposures. The subchronic study should include an extended histopathologic evaluation of the immunologic and neurologic systems. Multigeneration reproductive toxicity study via oral exposure. Carcinogenicity testing (2-year bioassay) via oral exposure.. Exposure levels in humans living near hazardous waste sites and other populations, such as exposed workers. ATSDR. Potential candidate for subregistry of exposed persons. ATSDR. 45B ....... 45C ...... 45D ...... 45E ....... 45F ....... 45G ...... Zinc ............................................... 46A ...... 46B ....... 46C ...... 46D ...... 46E ....... Program 2 1 Priority data need identification number. addressing priority data needs. ATSDR = ATSDR’s Division of Health Studies; EPA = U.S. Environmental Protection Agency; G. Lakes = Great Lakes Human Health Effects Research Program; MHPF = Minority Health Professions Foundation; NTP = National Toxicology Program; Vol Res = Voluntary research. 3 PDN can be filled or remain unchanged based on reevaluation of the database using criteria developed by ATSDR. 4 ACC = American Chemistry Council; Ashley et al. 1992 = Ashley DL, Bonin MA, Cardinali FL, et al. Anal Chem (1992) 64:1021–29; Ashley et al. 1994 = Ashley DL, Bonin MA, Cardinali FL et al., Clin Chem (1994) 40/7:1401–4; ATSDR studies = Studies conducted by ATSDR’s Division of Health Studies; GE = General Electric Company ; HSIA = Halogenated Solvents Industry Alliance, Inc.; MHPF = Minority Health Professions Foundation; MRL = Minimal Risk Level; CDC 2005 = The third National Report on Human Exposure to Environmental Chemicals, prepared by the National Center for Environmental Health, Centers for Disease Control and Prevention, Atlanta, GA; Needham et al. 1995 = Needham LL, Hill RH Jr, Ashley DL, Pirkle JL, and Sampson EJ. Environ Health Perspect 103(Suppl 3):89–94; Needham et al. 1996 = Needham LL, Patterson DG Jr, Burse VW, Paschal DC, Turner WE, and Hill VW Jr. Toxicol Ind Health 12:507–513; NHANES III = The Third National Health and Nutrition Examination Survey, conducted by the National Center for Health Statistics, Centers for Disease Control and Prevention, Atlanta, GA; NTP = National Toxicology Program; Paschal et al. 1998 = Paschal DC, Ting BC, Morrow JC, et al. Environ Res, Section A 76: 53–59; PBPK modeling = physiologically based pharmacokinetic modeling; Toxicological profile = ATSDR’s toxicological profiles for the Agency’s priority hazardous substances. 5 Not a priority data need. 2 Programs TABLE 2.—GROUPS WHICH ARE ADDRESSING/HAVE ADDRESSED ATSDR’S SUBSTANCE-SPECIFIC PRIORITY DATA NEEDS (PDNS) Program Firm, institution, agency, or consortium Substance Voluntarism .......................................... American Chemistry Council ............... General Electric Company .................. Halogenated Solvents Industry Alliance, Inc.. Vinyl Chloride ...................................... PCBs ................................................... Methylene chloride .............................. 44B, 44E 36H*, 36I*, 36J* 33A, 33B Tetrachloroethylene ............................. Trichloroethylene ................................. Lead ..................................................... 40B, 40C, 40D, 40E 43B, 43C, 43D, 43E 29A Minority Health Professions Foundation. VerDate Aug<31>2005 20:13 Nov 28, 2005 Florida A & M University ..................... Jkt 208001 PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 E:\FR\FM\29NON1.SGM 29NON1 PDN ID 71530 Federal Register / Vol. 70, No. 228 / Tuesday, November 29, 2005 / Notices TABLE 2.—GROUPS WHICH ARE ADDRESSING/HAVE ADDRESSED ATSDR’S SUBSTANCE-SPECIFIC PRIORITY DATA NEEDS (PDNS)—Continued Firm, institution, agency, or consortium Substance The King/Drew Medical Center of the Charles R. Drew University of Medicine and Science. Meharry Medical College .................... Morehouse School of Medicine ........... Texas Southern University .................. Lead ..................................................... 29B, 29C PAHs ................................................... Lead ..................................................... Di-n-butyl phthalate ............................. Lead ..................................................... Toluene ................................................ Trichloroethylene ................................. Chlordane ............................................ Mercury ................................................ Zinc ...................................................... Manganese .......................................... Zinc ...................................................... DDT/DDE ............................................. 37A, 37B, 37C, 37D 29C 21D 29A 41C 43B 9A 31A 46A, 46B 30A, 30B 46A 19D, 19E New York State Health Department .... State University of New York at Albany. State University of New York at Buffalo. Lead ..................................................... Mercury ................................................ PCBs ................................................... Selenium .............................................. DDT/DDE ............................................. Lead ..................................................... Mercury ................................................ PCBs ................................................... PCBs ................................................... 29C 31D 36D, 36E, 36J* 38D 19E 29C 31D 36D, 36E, 36J* 36E DDT/DDE ............................................. 19D, 19E Lead ..................................................... Mercury ................................................ PCBs ................................................... DDT/DDE ............................................. 29C 31D 36D, 36E, 36J* 19D, 19E Lead ..................................................... Mercury ................................................ PCBs ................................................... DDT/DDE ............................................. Lead ..................................................... Mercury ................................................ PCBs ................................................... DDT/DDE ............................................. 29C 31D 36D, 19D, 29C 31D 36D, 19D, Lead ..................................................... Mercury ................................................ PCBs ................................................... DDT/DDE ............................................. Lead ..................................................... Mercury ................................................ PCBs ................................................... Selenium .............................................. Arsenic ................................................. 29C 31D 36D, 36E, 36J* 19D, 19E 29C 31D 36A, 36D, 36E, 36J* 38D 2D Cadmium ............................................. Chromium ............................................ DDT/DDE ............................................. Lead ..................................................... Mercury ................................................ Nickel ................................................... PAHs ................................................... PCBs ................................................... Benzene .............................................. 7B 13E 19D, 19E 29C 31D 34F 37F 36D, 36E, 36J* 4A, 4B, 4C Chloroethane ....................................... Cyanide (hydrogen cyanide and sodium cyanide). Methylene chloride .............................. Tetrachloroethylene ............................. Toluene ................................................ Trichloroethylene ................................. 11A, 11B 14A, 14B Program Tuskegee University ............................ Xavier University ................................. Great Lakes Human Health Effects Research Program. Michigan State University .................... State University of New York at Oswego. University of Illinois at Chicago ........... University of Illinois at Urbana-Champaign. University of Wisconsin-Milwaukee ..... Wisconsin Department of Health and Social Services—5 State Consortium. Environmental Protection TSCA/FIFRA. VerDate Aug<31>2005 20:13 Nov 28, 2005 Agency EPA/ATSDR Test Rule ....................... Jkt 208001 PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 E:\FR\FM\29NON1.SGM 29NON1 PDN ID 36E, 36J* 19E 36E, 36J* 19E 33A 40C, 40E 41C 43B, 43E 71531 Federal Register / Vol. 70, No. 228 / Tuesday, November 29, 2005 / Notices TABLE 2.—GROUPS WHICH ARE ADDRESSING/HAVE ADDRESSED ATSDR’S SUBSTANCE-SPECIFIC PRIORITY DATA NEEDS (PDNS)—Continued Firm, institution, agency, or consortium Substance Metals Testing Task Force (TASARC) Arsenic ................................................. Beryllium .............................................. Chromium ............................................ Manganese .......................................... Mercury ................................................ Nickel ................................................... Selenium .............................................. Carbon tetrachloride ............................ 2A, 2B, 2C 6A, 6B, 6C, 6E 13A, 13B, 13C, 13D 30A, 30B, 30E 31C 34B, 34C, 34D, 34E 38A, 38B 8B 1,1-dichloroethene ............................... Di-n-butyl phthalate ............................. Disulfoton ............................................. Heptachlor ........................................... 18A, 18B 21A 22A 26B Program National Toxicology Program .............. * Not National Institute of Carbon Environmental Health Sciences. PDN ID priority data needs. [FR Doc. 05–23361 Filed 11–28–05; 8:45 am] BILLING CODE 4163–70–P DEPARTMENT OF HEALTH AND HUMAN SERVICES FOR FURTHER INFORMATION CONTACT: Administration on Aging 2005 White House Conference on Aging Administration on Aging, HHS. Notice of meeting and final Annotated Agenda. AGENCY: ACTION: SUMMARY: Pursuant to section 10(a) of the Federal Advisory Committee Act as amended (5 U.S.C. Appendix 2), notice is hereby given of the 2005 White House Conference on Aging (WHCoA) meeting in December 2005 and the final Annotated Agenda for the 2005 WHCoA. The Policy Committee approved this final Annotated Agenda during a meeting held by conference call on November 3, 2005. The Annotated Agenda covers six broad areas that reflect major issues facing older individuals now and for the next 10 years. The 2005 WHCoA will be open to the public. Individuals who wish to attend should call or email the contact person listed below in advance of the meeting and inform her of the day they wish to attend; since space for the public is limited, attendance will be on a first come first-served basis. Individuals who need special assistance, such as sign language interpretation or other reasonable accommodations, should inform the contact person of the type of assistance that is desired. DATES: The 2005 White House Conference on Aging will take place from Sunday, December 11, 2005 to Wednesday, December 14, 2005. VerDate Aug<31>2005 20:13 Nov 28, 2005 Jkt 208001 The 2005 White House Conference on Aging will be held at the Marriott Wardman Park Hotel, 2660 Woodley Road, NW., Washington, DC 20008. ADDRESSES: Rada Spencer at (301) 443–2496, or email at Rada.Spencer@whcoa.gov. SUPPLEMENTARY INFORMATION: Pursuant to the Older Americans Act Amendments of 2000 (Pub. L. 106–501, November 2000), the President will convene the White House Conference on Aging (WHCoA) not later than December 31, 2005. Specifically, the statute requires that the WHCoA shall gather individuals representing the spectrum of thought and experience in the field of aging to develop not more than 50 recommendations to guide the President, Congress, and Federal agencies in serving older individuals. The 2005 WHCoA will be held at the Marriott Wardman Park Hotel in Washington, DC from Sunday, December 11, 2005 to Wednesday, December 14, 2005. During its open meeting on October 1, 2004, the Policy Committee approved a proposed broad agenda, with the knowledge that work would continue on the Annotated Agenda. The broad agenda focused on six areas: Planning for the Future, Employment, Our Community, Health and Long-Term Living, Social Engagement, and Marketplace, and it was placed on the WHCoA Web site at https://www.whcoa.gov for public comment. The Policy Committee received comments from testimony and reports submitted from over 400 Listening Sessions, Solutions Forums, Mini-Conferences, and Independent Aging Agenda Events held and attended by approximately 130,000 individuals, as well as from unsolicited public comments to refine the proposed PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 Annotated Agenda. Section 202 (b)(1) of the statute requires that the agenda for the WHCoA shall be published in the Federal Register not later than 30 days after the agenda is approved by the Policy Committee. The Policy Committee approved the final Annotated Agenda, dated November 3, 2005, during a meeting held by conference call on November 3, 2005. The six broad areas have been refined to read: (1) Planning Along the Lifespan, (2) The Workplace of the Future, (3) Our Community, (4) Health and Long-Term Living, (5) Civic Engagement and Social Engagement and (6) Technology and Innovation in an Emerging Senior/ Boomer Marketplace. The entire text of the final Annotated Agenda is published as an Appendix to this notice. Dated: November 23, 2005. Edwin L. Walker, Deputy Assistant Secretary for Policy and Programs. Appendix 1—2005 White House Conference on Aging Annotated Agenda** Final—November 3, 2005 I. Planning Along the Lifespan Social Security, pensions, savings, and wages each serve an important role in ensuring financial security in retirement. A cornerstone of achieving financial security in retirement is planning throughout a lifetime. Effective savings incentives and financial education are essential planning tools. Starting to save for retirement as early as possible ensures the miracle of compound interest, and provides optimum leverage. However, accumulating savings by itself does not guarantee a secure retirement. Managing those assets through longer and longer lifespans is also a key component. Americans must plan and prepare for the risk of having assets depleted E:\FR\FM\29NON1.SGM 29NON1

Agencies

[Federal Register Volume 70, Number 228 (Tuesday, November 29, 2005)]
[Notices]
[Pages 71506-71531]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-23361]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substances and Disease Registry

[ATSDR-215]


Update on the Status of the Superfund Substance-Specific Applied 
Research Program

AGENCY: Agency for Toxic Substances and Disease Registry (ATSDR), U.S. 
Department of Health and Human Services (HHS).

ACTION: Notice.

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SUMMARY: This Notice provides the status of ATSDR's Superfund-mandated 
Substance-Specific Applied Research Program (SSARP) which was last 
updated in a Federal Register notice in 2002 (67 FR 4836). Authorized 
by the Comprehensive Environmental Response, Compensation, and 
Liability Act of 1980 (CERCLA, also known as the Superfund statute), as 
amended by the Superfund Amendments and Reauthorization Act of 1986 
(SARA) [42 U.S.C. 9604 (i)], this research program was initiated on 
October 17, 1991. At that time, a list of priority data needs for 38 
priority hazardous substances frequently found at waste sites was 
announced in the Federal Register (56 FR 52178). The list was 
subsequently revised based on public comments and published in final 
form on November 16, 1992 (57 FR 54150).
    The 38 substances, each of which is found on ATSDR's Priority List 
of Hazardous Substances (68 FR 63098, November 7, 2003), are aldrin/
dieldrin, arsenic, benzene, beryllium, cadmium, carbon tetrachloride, 
chloroethane, chloroform, chromium, cyanide, p,p'-DDT,DDE,DDD, di(2-
ethylhexyl) phthalate, lead, mercury, methylene chloride, nickel, 
polychlorinated biphenyl compounds (PCBs), polycyclic aromatic 
hydrocarbons (PAHs--includes 15 substances), selenium, 
tetrachloroethylene, toluene, trichloroethylene, vinyl chloride, and 
zinc.
    On July 30, 1997, priority data needs for 12 additional hazardous 
substances frequently found at waste sites were determined and 
announced in the Federal Register (62 FR 40820). The 12 substances, 
each of which is included in ATSDR's Priority List of Hazardous 
Substances, are chlordane, 1,2-dibromo-3-chloropropane, di-n-butyl 
phthalate, disulfoton, endrin (includes endrin aldehyde), endosulfan 
(alpha-, beta-, and endosulfan sulfate), heptachlor (includes 
heptachlor epoxide), hexachlorobutadiene, hexachlorocyclohexane (alpha-
, beta-, delta- and gamma-), manganese, methoxychlor, and toxaphene.
    More recently, priority data needs for 10 additional hazardous 
substances frequently found at waste sites were determined and 
announced in the Federal Register (68 FR 22704). The ten substances, 
each of which is included in ATSDR's Priority List of Hazardous 
Substances, are asbestos, benzidine, chlorinated dibenzo-p-dioxins, 
1,2-dibromoethane, 1,2-dichloroethane, 1,1-dichloroethene, 
ethylbenzene, pentachlorophenol, 1,1,2,2-tetrachloroethane, and total 
xylenes.
    Currently, the priority data needs for acrolein and barium are 
being identified and will be reported in a future Federal Register 
notice.
    To date, 270 priority data needs have been identified for the 60 
hazardous substances, and 86 priority data needs have been filled 
(Table 1). ATSDR fills these research needs through U.S. Environmental 
Protection Agency (EPA) regulatory mechanisms (test rules), private-
sector voluntarism, and the direct use of CERCLA funds. Additional 
priority data needs are being addressed through collaboration with the 
National Toxicology Program (NTP), by ATSDR's Great Lakes Human Health 
Effects Research Program, and other Agency programs. Priority data 
needs documents describing ATSDR's rationale for prioritizing research 
needs for each substance are available. See ADDRESSES section of this 
Notice.
    This Notice also serves as a continuous call for voluntary research 
proposals. Private-sector organizations may volunteer to conduct 
research to address specific priority data needs identified in this 
Notice by indicating their interest through submission of a letter of 
intent to ATSDR (see ADDRESSES section of this Notice). A Tri-Agency 
Superfund Applied Research Committee (TASARC) composed of scientists 
from ATSDR, National Institute of Environmental Health Sciences 
(NIEHS)/NTP, and the EPA, will review all proposed voluntary research 
studies.

DATES: ATSDR provides updates on the status of its Substance-Specific 
Applied Research Program approximately every three years or sooner, as 
needed. ATSDR considers the voluntary research effort to be important 
to the continuing implementation of the SSARP. Therefore, the Agency 
strongly encourages private-sector organizations to volunteer at any 
time to conduct research to fill data needs until ATSDR announces that 
other research mechanisms are in place to address those specific data 
needs.

ADDRESSES: Private-sector organizations interested in volunteering to 
conduct research can write to Yee-Wan Stevens, M.S., Applied Toxicology 
Branch, Division of Toxicology and Environmental Medicine, ATSDR, 1600 
Clifton Road, NE., Mailstop F-32, Atlanta, Georgia 30333, e-mail: 
YStevens@cdc.gov. Information about pertinent ongoing or completed 
research that may fill priority data needs cited in this Notice should 
be similarly addressed.
    Other Requirements: Projects that involve the collection of 
information from ten or more individuals and funded by cooperative 
agreement will be subject to review by the Office of

[[Page 71507]]

Management and Budget (OMB) under the Paperwork Reduction Act.

FOR FURTHER INFORMATION CONTACT: Yee-Wan Stevens, M.S., Applied 
Toxicology Branch, Division of Toxicology and Environmental Medicine, 
ATSDR, 1600 Clifton Road, NE., Mailstop F-32, Atlanta, Georgia 30333, 
telephone: (770) 488-3325, fax: (770) 488-4178.

SUPPLEMENTARY INFORMATION:

Background

    CERCLA as amended by SARA [42 U.S.C. 9604(i)] requires that ATSDR 
(1) jointly with the EPA, develop and prioritize a list of hazardous 
substances found at National Priorities List (NPL) sites, (2) prepare 
toxicological profiles for these substances, and (3) assure the 
initiation of a research program, in conjunction with NTP, to address 
identified data needs associated with the substances. Before starting 
such a program, ATSDR will consider recommendations of the InterAgency 
Testing Committee on the type of research that should be done. This 
committee was established under section 4(e) of the Toxic Substances 
Control Act of 1976 [15 U.S.C. 2604(e)](TSCA).
    The major goals of the ATSDR SSARP are (1) to address the 
substance-specific information needs of the public and scientific 
community, and (2) to supply information necessary to improve the 
database used to conduct comprehensive public health assessments of 
populations living near hazardous waste sites. We anticipate that the 
information will help to establish linkages between levels of 
contaminants in the environment and levels in human tissue and organs 
associated with adverse health effects. Once such links have been 
established, strategies to mitigate potentially harmful exposures can 
be developed. This program will also provide data that can be 
generalized to other substances or areas of science, including risk 
assessment of chemicals, thus creating a scientific information base 
for addressing a broader range of data needs.
    ATSDR encourages the use of in vitro assessment methods and other 
innovative tools for filling priority data needs. For example, the 
Agency believes that physiologically based pharmacokinetic (PBPK) 
modeling could serve as a valuable tool in predicting across route 
similarities (or differences) in toxicological responses to hazardous 
substances. Therefore, on a case-by-case basis, a priority data need 
can be filled using existing data and modeling. In addition, ATSDR is a 
member of NTP's InterAgency Coordinating Committee on the Validation of 
Alternative Methods (ICCVAM) and supports development, validation, and 
acceptance of alternative toxicological test methods that reduce, 
refine, and replace the use of animals, as appropriate.
    CERCLA section 104(i)(5)(D) states that it is the sense of Congress 
that the costs for conducting this research program ``be borne by the 
manufacturers and processors of the hazardous substance in question,'' 
as required in TSCA and the Federal Insecticide, Fungicide, and 
Rodenticide Act of 1972 [7 U.S.C. 136 et seq.] (FIFRA), or by cost 
recovery from responsible parties under CERCLA. To execute this 
statutory intent, ATSDR developed a plan whereby parts of the SSARP are 
being conducted via the regulatory mechanisms referenced (TSCA/FIFRA), 
private-sector voluntarism, and the direct use of CERCLA funds.
    The TASARC, composed of scientists from ATSDR, NIEHS/NTP, and EPA, 
has been set up to:
    (1) Advise ATSDR on the assignment of priorities for mechanisms to 
address data needs,
    (2) Coordinate knowledge of research activities to avoid 
duplication of research in other programs and under other authorities,
    (3) Advise ATSDR on issues of science related to substance-specific 
data needs, and
    (4) Maintain a scheduled forum that provides an overall review of 
the ATSDR SSARP.
    TASARC has met 12 times since the initiation of the SSARP. It has 
guided referral of priority data needs to EPA and the associated 
development of test rules through TSCA. In addition, it has endorsed 
the proposals of several private-sector organizations to conduct 
voluntary research. Furthermore, TASARC has become a forum for other 
federal agencies to bring forth their research agendas. For example, it 
has coordinated research efforts on hazardous pollutants with the 
Office of Air and Radiation, EPA. TASARC has developed testing 
guidelines for immunotoxicity; and has endorsed the use of decision-
support methodologies such as physiologically based pharmacokinetic 
(PBPK) modeling and benchmark-dose modeling, where appropriate.
    Additional priority data needs are being addressed through 
collaborative research efforts with NTP, by ATSDR's Great Lakes Human 
Health Effects Research Program, and other Agency programs.

Criteria for Evaluating Status of Priority Data Needs

    To update the activities covered under the SSARP, criteria for 
evaluating the status of the priority data needs were developed. Based 
on these criteria and the review of the current literature, a priority 
data need can be filled, or unchanged.
    The criteria for evaluating the status of the priority data needs 
are described below.

General Criteria

    A priority data need is filled:
     If it has been referred to one of the implementation 
mechanisms and research has been initiated (Exception: priority data 
needs referred to EPA [i.e., included in the EPA/ATSDR test rule] and/
or ATSDR Voluntary Research Program remain as priority data needs until 
the studies have been completed, peer reviewed and accepted by ATSDR), 
or
     If an updated ATSDR toxicological profile contains 
relevant new studies, or if other relevant, peer-reviewed, and publicly 
available new studies (not included in the toxicological profile) have 
been identified since the finalization of the priority data needs 
document; and based on such studies, it is generally agreed that a 
priority data need has been filled.
    Furthermore, in the event a priority data need is considered 
filled, it does not necessarily mean that the study has been completed 
and that ATSDR has accepted the data. It does, however, indicate that 
the Agency no longer considers it a priority to initiate additional 
studies at this time.
    A priority data need remains unchanged:
     If no mechanism or information has been identified to 
address the priority data need, or
     If the priority data need is included in the ATSDR/EPA 
test rule under development and/or ATSDR Voluntary Research Program, or 
it is associated with a pilot substance in EPA's Voluntary Children's 
Chemical Evaluation Program.

Specific Criteria

    Examples of specific criteria for two categories of priority data 
needs are described below.
     Epidemiologic studies--A priority data need is filled if 
multiple new studies assessing key health end points are available in 
ATSDR's updated toxicological profile and/or ongoing studies have been 
identified, e.g., human health studies supported by ATSDR's Great Lakes 
Human Health

[[Page 71508]]

Effects Research Program or the Minority Health Professions Foundation 
Research Program. In some cases, ATSDR indicates that it will continue 
to evaluate new data as they become available to determine whether 
additional studies are needed.
     Exposure levels in humans (adults and/or children)--A 
priority data need is filled if (a) there are current and adequate 
biomonitoring data for exposed populations associated with health 
effects (from published or ongoing studies), or (b) there are reference 
range data (e.g., the Centers for Disease Control and Prevention's 
Third National Report on Human Exposure to Environmental Chemicals, 
with data from a random sample of participants from the National Health 
and Nutrition Examination Survey [NHANES]) or generally agreed upon 
background population levels. In the latter case, ATSDR acknowledges 
that reference concentration data can support exposure and health 
assessments at waste sites, but the Agency also continues to recognize 
the importance of collecting additional data on uniquely exposed 
populations at waste sites. It should be noted that for some of the 
chemicals listed in the National Report, the measurements are reported 
as below the limit of detection (LOD) for those chemicals. However, the 
LODs for all the chemicals monitored are available in the Report, and 
therefore, these data can be considered as estimates of background 
exposure levels.
    In updating the SSARP, the status of the priority data needs may 
change as new information becomes available. Further, during the 
literature review, new studies may be identified suggesting other 
effects of concern, such as those related to endocrine disruptors and 
children's health, which were not included in the original list of 
priority data needs. In such cases, additional priority data needs may 
be added to the research agenda. For example, in addressing issues 
relating to children's health, ATSDR considers it a priority to obtain 
data on exposure levels in children; therefore, when such information 
is available, it is used to fill this additional priority data need 
(e.g., cadmium, chlordane, chlorinated dibenzo-p-dioxins, DDT, lead, 
and pentachlorophenol, see Table 1).
    In contrast, the Agency may consider a previously identified 
priority data need to no longer be a priority to fill at this time and 
thus be deleted from the list of priority data needs. However, it 
remains a data need for the Agency. For example, as a result of 
reevaluation of the database for di-n-butyl phthalate, two of its 
previously identified priority data needs, i.e., immunotoxicity and 
neurotoxicity studies via oral exposure are no longer considered to be 
priority data needs. This is due to the fact that the immune system 
does not appear to be a target for di-n-butyl phthalate toxicity and 
that additional neurotoxicity studies do not seem necessary because of 
the lack of effects seen in long-term neurotoxicity studies. In 
addition, under the Agency's Voluntary Research Program, the 
Halogenated Solvents Industry Alliance, Inc. (HSIA) proposed to fill a 
trichloroethylene priority data need (dose-response data for 
intermediate-duration, oral exposure) by conducting PBPK modeling to 
obtain the data for oral exposure using existing inhalation data. 
However, ATSDR is concerned that, based on the existing data for this 
exposure duration, it is not clear if the most sensitive end point for 
oral exposure is the same as that for inhalation exposure. Therefore, 
the Agency believes it is prudent not to consider it a priority to 
conduct a PBPK study to obtain the oral data at this time pending 
evaluation of additional information. This is reflected in Table 1 from 
which this priority data need has been deleted.

Update of Activities in the SSARP

    An update of the activities associated with the mechanisms for 
implementing the ATSDR Substance-Specific Applied Research Program 
(SSARP) is discussed below.

A. TSCA/FIFRA

    In developing and implementing the SSARP, ATSDR, NIEHS/NTP, and EPA 
have identified a subset of priority data needs for substances of 
mutual interest to the federal programs. These priority data needs are 
being addressed through a program of toxicological testing under TSCA 
according to established procedures and guidelines. On several 
occasions when ATSDR identified priority data needs for oral exposure, 
other agencies needed inhalation data. In response, ATSDR considers 
proposals to conduct inhalation studies in conjunction with 
physiologically based pharmacokinetic (PBPK) studies in lieu of oral 
studies. ATSDR expects that inhalation data derived from these studies 
can be used with PBPK modeling to address its oral toxicity priority 
data needs. Currently, an EPA/ATSDR test rule, under development, 
includes eight ATSDR substances, i.e., benzene, chloroethane, cyanide 
(hydrogen cyanide and sodium cyanide), methylene chloride, 
tetrachloroethylene, toluene and trichloroethylene, and addresses 13 
ATSDR priority data needs (Table 2). The test rule is presently 
undergoing ATSDR and EPA final review and is anticipated to be 
available for public comment in Spring 2006.
    At least seven metals included in the ATSDR's SSARP (arsenic, 
beryllium, chromium, manganese, mercury, nickel, and selenium, 
associated with 21 priority data needs) (Table 2) have been forwarded 
to EPA through TASARC for toxicity testing. The EPA is currently 
developing a risk assessment framework for metals. Once the framework 
has been adopted, the EPA will solicit testing proposals for these 
metals and pursue appropriate testing mechanisms at a later date.

B. Private-Sector Voluntarism

    As part of the Substance-Specific Applied Research Program (SSARP), 
ATSDR announced a set of proposed procedures for conducting voluntary 
research in the Federal Register (57 FR 4758) on February 7, 1992. 
Revisions based on public comments were published on November 16, 1992 
(57 FR 54160). Private-sector organizations are encouraged to volunteer 
to conduct research to fill specific priority data needs at no expense 
to ATSDR. All study protocols and final reports are subjected to 
ATSDR's external peer review, and ATSDR accepts the study results based 
on the peer reviewers' recommendation and the industry groups' 
satisfactory response to the reviewers' comments.
    To date, ATSDR has established memoranda of understanding with four 
industry groups. Through the voluntary research efforts of these 
organizations, at least 15 research needs (12 priority data needs and 3 
data needs) for methylene chloride, tetrachloroethylene 
(perchloroethylene), trichloroethylene, polychlorinated biphenyl 
compounds [PCBs], and vinyl chloride have been or are being filled 
(Table 2).
    Industry groups which conducted studies under the Voluntary 
Research Program include:

The American Chemistry Council (ACC) [Formerly the Chemical 
Manufacturers Association (CMA)]

    ATSDR accepted the ACC studies ``Vinyl chloride: Combined 
inhalation two-generation reproduction and developmental toxicity study 
in CD rats.''

General Electric Company (GE)

    GE conducted studies on polychlorinated biphenyls including ``An 
assessment of the chronic toxicity and oncogenicity of Aroclors 1016,

[[Page 71509]]

1242, 1254, and 1260 administered in diet to rats,'' ``PCB congener 
analyses,'' and ``Metabolite detection as a tool for determining 
naturally occurring aerobic PCB biodegradation.'' Although these 
studies do not specifically address ATSDR's priority data needs for 
PCBs, they do address other Agency research needs for these substances.

Halogenated Solvents Industry Alliance, Inc. (HSIA)

    To date, ATSDR has entered into five MOUs with HSIA to conduct 
studies to fill priority data needs for methylene chloride, 
tetrachloroethylene and trichloroethylene. In addition, in 2002, HSIA 
signed a letter of agreement with ATSDR stating that HSIA volunteers to 
conduct studies to fill ATSDR's remaining priority data needs for 
tetrachloroethylene (perchloroethylene) and trichloroethylene. These 
studies are being done in conjunction with the EPA/ATSDR test rule and 
EPA's Voluntary Children's Chemical Evaluation Program. In some cases, 
HSIA first conducted a study via inhalation which was followed by route 
extrapolation via PBPK modeling to obtain data for oral exposure. This 
is because, for specific chemicals, EPA requires inhalation data while 
ATSDR has determined that ingestion of contaminated environmental media 
is the primary exposure route at hazardous waste sites.
    HSIA studies accepted by ATSDR include:
    ``Addressing priority data needs for methylene chloride with 
physiologically based pharmacokinetic modeling'' which evaluates acute- 
and subchronic-duration toxicity and developmental toxicity via oral 
exposure.
    ``Methylene chloride: 28 day inhalation toxicity study in the rat 
to assess potential immunotoxicity.''
    ``Immunotoxic potential of orally administered dichloromethane from 
immunotoxicity studies conducted by the inhalation route.'' (PBPK 
modeling)
    ``Trichloroethylene: Inhalation developmental toxicity study in CD 
rats.'' HSIA will conduct PBPK modeling to obtain data for oral 
exposure based on the inhalation data.
    ``Trichloroethylene (TCE): Immunotoxicity potential in CD rats 
following a 4-week vapor inhalation exposure.'' The final report of the 
study is undergoing ATSDR's external peer review. Pending ATSDR's 
acceptance of the inhalation study, HSIA will conduct PBPK modeling to 
obtain data for oral exposure based on the inhalation data.
    ``Perchloroethylene: Study of effects on embryo-fetal development 
in CD rats by inhalation administration.'' HSIA will conduct PBPK 
modeling to obtain data for oral exposure based on the inhalation data.

Electric Power Research Institute, Inc. (EPRI)

    In addition to the substance-specific MOUs described above, ATSDR 
also signed an MOU with EPRI to conduct a study ``Validation of test 
methods for assessing neurodevelopment in children.'' In this 
particular case, ATSDR and three other federal agencies (the Food and 
Drug Administration, EPA, and NIEHS) were also funding partners.

C. CERCLA-Funded Research (Minority Health Professions Foundation 
Research Program)

    During FY 1992, ATSDR announced a $4 million cooperative agreement 
program with the Minority Health Professions Foundation (MHPF) to 
support substance-specific investigations. A not-for-profit Internal 
Revenue Code 501(c)(3) organization, the MHPF comprises 11 minority 
health professions schools at historically black colleges and 
universities. The MHPF mission is to research health problems that 
disproportionately affect poor and minority citizens. The purpose of 
the cooperative agreement was to address substance-specific data needs 
for priority hazardous substances identified by ATSDR. In addition, the 
agreement strengthened the environmental health research opportunities 
for scientists and students at MHPF member institutions and enhanced 
existing disciplinary capacities to conduct research in toxicology and 
environmental health. The MHPF published a report, ``Environmental 
Health and Toxicology Research Program: Meeting Environmental Health 
Challenges Through Research, Education, and Service,'' that describes 
the research findings and other successes from the first 5 years of the 
program.
    In the first five year project period that concluded during FY 
1997, nine priority data needs for 21 priority hazardous substances and 
22 other research needs for these and other substances were addressed. 
Research initiated in the second 5-year project period included studies 
to address 10 additional priority data needs for chlordane, di-n-butyl 
phthalate, lead, manganese, the polycylic aromatic hydrocarbons (PAHs), 
zinc, and eight other research needs. To date, 14 priority data needs 
have been filled through this cooperative agreement (Table 1).
    During 2003, ATSDR announced a new five year cooperative agreement 
program with the MHPF. The purpose of the program is to apply findings 
from the previous ten year environmental health and Toxicology Research 
Program and to improve public health and environmental medicine in low-
income and minority communities. The new program builds on earlier 
efforts and expands the Program's public environmental health impact on 
affected communities. Activities across the following four research and 
environmental public health focus areas were funded to initiate this 
new program: substance-specific toxicology research, environmental 
exposure assessment, community-based environmental health education, 
and environmental health education for primary-care providers. No 
additional priority data needs are being addressed under this new 
program.
    To date, Program research findings and other activities have 
resulted in the publication of more than 50 manuscripts in peer-
reviewed journals. The institutions which have received awards and 
their respective studies are listed in Table 2.

D. National Toxicology Program (NTP)

    Section 104(i)(5) of CERCLA directs the administrator of ATSDR (in 
consultation with the administrator of EPA and agencies and programs of 
the Public Health Service) to assess whether adequate information on 
the health effects of priority hazardous substances found at NPL sites 
is available. Where adequate information is not available, ATSDR, in 
cooperation with the National Toxicology Program (NTP), is required to 
assure the initiation of a program of research designed to determine 
these health effects (and techniques for developing methods to 
determine such health effects).
    ATSDR continues to collaborate with NTP to address priority data 
needs of mutual interest. Chemicals for which NTP has conducted studies 
(or is in the process of conducting studies) to fill ATSDR's priority 
data needs include carbon tetrachloride, 1,1-dichloroethene, di-n-butyl 
phthalate, disulfoton, and heptachlor (Table 2).

E. Great Lakes Human Health Effects Research Program

    Some of the priority data needs identified in the SSARP have been 
independently identified as research needs through the ATSDR Great 
Lakes Human Health Effects Research Program, a separate research 
program.
    In support of the Great Lakes Critical Programs Act of 1990, ATSDR 
announced in Fiscal Year 1992 the availability of $2 million for a 
grant

[[Page 71510]]

program to conduct research on the potential for short- and long-term 
adverse health effects from consumption of contaminated fish from the 
Great Lakes basin. Research undertaken through this program is intended 
to build on and amplify the results of past and ongoing fish 
consumption research in the Great Lakes basin. The ATSDR-supported 
research projects focus on known high-risk populations to define 
further the human health consequences of exposure to persistent toxic 
substances (PTSs) identified in the Great Lakes basin. These at-risk 
populations include sport anglers; African Americans, Asians and other 
non-English speaking populations; pregnant women; fetuses, nursing 
infants, and children of mothers who consume contaminated Great Lakes 
sport fish; the elderly, and the urban poor. To date, the research 
activities of the ATSDR Great Lakes Human Health Effects Research 
Program have resulted in 70 publications in peer-reviewed journals.
    Currently, 14 priority data needs for 24 priority hazardous 
substances (including 15 PAHs) identified in the SSARP are being 
addressed through this program. The institutions which have received 
awards and their respective studies are listed in Table 2.

F. Other ATSDR Programs

    In its role as a public health agency addressing environmental 
health, ATSDR may collect human data to validate substance-specific 
exposure and toxicity findings. The need for additional information on 
levels of contaminants in humans has been identified, and remains as a 
priority data need for 59 of the 60 priority substances (Table 1). In 
some cases, ATSDR anticipates obtaining this information 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. Regarding the priority data need for exposure 
subregistries, the list of the 60 priority hazardous substances in the 
SSARP was forwarded to ATSDR's Division of Health Studies for 
consideration as potential candidates for subregistries of exposed 
persons, based on criteria described in its 1994 document, ``National 
Exposure Registry: Policies and Procedures Manual (Revised),'' Agency 
for Toxic Substances and Disease Registry, Public Health Service, U.S. 
Department of Health and Human Services, Atlanta, Georgia, NTIS 
Publication No. PB95-154571. Currently, ATSDR has established exposure 
subregistries for benzene, dioxin, 1,1,1-trichloroethane (not included 
in the SSARP), trichloroethylene, and tremolite asbestos.

G. Conclusion

    The results of the research conducted via the SSARP are expected to 
provide information necessary to improve the database used to conduct 
comprehensive public health assessments of populations living near 
hazardous waste sites. The information will enable the Agency to 
establish linkages between levels of contaminants in the environment 
and levels in human tissue and organs associated with adverse health 
effects, ultimately helping to determine methods for interdicting 
exposure and mitigating toxicity. This program will also provide data 
that can be generalized to other substances or areas of science, 
including risk assessment of chemicals, thus creating a scientific 
information base for addressing a broader range of data needs. The 
Agency plans to provide an update on the status of this research 
program approximately every three years or sooner, as needed.

    Dated: November 17, 2005.
Kenneth Rose,
Acting Director, Office of Policy, Planning, and Evaluation, National 
Center for Environmental Health, Agency for Toxic Substances and 
Disease Registry.

          Table 1.--ATSDR's Substance-Specific Priority Data Needs for 60 Priority Hazardous Substances
----------------------------------------------------------------------------------------------------------------
                                                                                 Status change
          Substances             PDN ID \1\    PDN description    Program \2\         \3\         Comments \4\
----------------------------------------------------------------------------------------------------------------
Aldrin/Dieldrin...............  1A..........  Dose-response     ..............  Filled........  An MRL was
                                               data in animals                                   derived in the
                                               for                                               2000 updated
                                               intermediate-                                     ATSDR
                                               duration oral                                     toxicological
                                               exposure.                                         profile.
                                1B..........  Bioavailability
                                               from soil.
                                1C..........  Exposure levels   ..............  ..............  This priority
                                               in humans                                         data need,
                                               living near                                       previously
                                               hazardous waste                                   addressed in a
                                               sites and other                                   study in the
                                               populations,                                      Great Lakes
                                               such as exposed                                   Research
                                               workers.                                          Program, is no
                                                                                                 longer
                                                                                                 investigated in
                                                                                                 that study.
                                1D..........  Potential         ATSDR.........
                                               candidate for
                                               subregistry of
                                               exposed persons.
Arsenic.......................  2A..........  Comparative       EPA...........
                                               toxicokinetic
                                               studies to
                                               determine if an
                                               appropriate
                                               animal species
                                               can be
                                               identified.
                                2B..........  Half-lives in     EPA...........
                                               surface water,
                                               groundwater.
                                2C..........  Bioavailability   EPA...........
                                               from soil.

[[Page 71511]]

 
                                2D..........  Exposure levels   G. Lakes......  Filled........  In addition to
                                               in humans                                         the data from
                                               living near                                       the Great Lakes
                                               hazardous waste                                   Research
                                               sites and other                                   Program,
                                               populations,                                      background
                                               such as exposed                                   level data are
                                               workers.                                          available in
                                                                                                 ATSDR's 1993
                                                                                                 toxicological
                                                                                                 profile, and at
                                                                                                 least seven
                                                                                                 ATSDR studies
                                                                                                 that evaluated
                                                                                                 urine arsenic
                                                                                                 levels and
                                                                                                 potential
                                                                                                 adverse health
                                                                                                 effects are
                                                                                                 available.
                                                                                                 Also,
                                                                                                 additional
                                                                                                 studies are
                                                                                                 available in
                                                                                                 ATSDR's 2000
                                                                                                 updated
                                                                                                 toxicological
                                                                                                 profile.
Asbestos......................  3A..........  Epidemiologic
                                               studies of
                                               individuals
                                               occupationally
                                               exposed to
                                               asbestos levels
                                               lower than
                                               those
                                               experienced
                                               before the
                                               institution of
                                               current
                                               occupational
                                               standards
                                               governing the
                                               use of
                                               asbestos, but
                                               higher than
                                               current levels
                                               in the general
                                               population.
                                               These studies
                                               should be
                                               performed in
                                               conjunction
                                               with the
                                               immunotoxicity
                                               studies.
                                3B..........  Immunotoxicity
                                               studies of
                                               individuals
                                               occupationally
                                               exposed to
                                               asbestos.
                                3C..........  Development of
                                               human and rat
                                               lung retention
                                               models to aid
                                               in
                                               extrapolating
                                               between rat and
                                               human data.
                                3D..........  Improved
                                               analytical
                                               methods for
                                               screening
                                               samples and
                                               determining the
                                               chemical
                                               structure of
                                               asbestos
                                               fibers. Also,
                                               techniques are
                                               needed to
                                               normalize
                                               studies in
                                               which different
                                               analytical
                                               methods were
                                               employed.
                                3E..........  Exposure levels,
                                               fiber size
                                               distribution,
                                               and asbestos
                                               fiber type in
                                               areas with
                                               natural
                                               geologic
                                               deposits of
                                               friable
                                               asbestos and at
                                               hazardous waste
                                               sites. Also,
                                               techniques for
                                               estimating air
                                               levels of
                                               asbestos from
                                               soil
                                               concentrations
                                               and activity
                                               scenarios.
                                3F..........  Exposure levels
                                               in humans
                                               living near
                                               hazardous waste
                                               sites and in
                                               other
                                               populations,
                                               such as humans
                                               living in areas
                                               with naturally
                                               high levels of
                                               friable
                                               asbestos.
                                3G..........  Potential         ATSDR.........  Filled........  ATSDR
                                               candidate for                                     established
                                               subregistry of                                    registry to
                                               exposed persons.                                  follow the
                                                                                                 health of
                                                                                                 people who were
                                                                                                 exposed to
                                                                                                 asbestos in
                                                                                                 Libby, Montana.
                                                                                                 The name of the
                                                                                                 registry is the
                                                                                                 Tremolite
                                                                                                 Asbestos
                                                                                                 Registry (TAR).
Benzene.......................  4A..........  Dose-response     EPA...........  ..............  Reproductive
                                               data in animals                                   toxicity study
                                               for acute- and                                    is the only
                                               intermediate-                                     component of
                                               duration oral                                     this PDN that
                                               exposure. The                                     is included in
                                               subchronic                                        the EPA/ATSDR
                                               study should                                      test rule.
                                               include an
                                               extended
                                               reproductive
                                               organ
                                               histopathology.

[[Page 71512]]

 
                                4B..........  Prenatal          EPA...........  ..............  Previously
                                               developmental                                     planned study
                                               toxicity study                                    in the MHPF
                                               via oral                                          Research
                                               exposure.                                         Program to
                                                                                                 address this
                                                                                                 priority data
                                                                                                 need was
                                                                                                 canceled.
                                4C..........  Neurotoxicology   EPA...........
                                               battery of
                                               tests via oral
                                               exposure.
                                4D..........  Epidemiologic     ..............  Filled........  Based on an
                                               studies on the                                    evaluation of
                                               health effects                                    the data in
                                               of benzene                                        ATSDR's 1997
                                               (Special                                          updated
                                               emphasis end                                      toxicological
                                               points include                                    profile. ATSDR
                                               immunotoxicity).                                  will continue
                                                                                                 to evaluate new
                                                                                                 data as they
                                                                                                 become
                                                                                                 available to
                                                                                                 determine if
                                                                                                 additional
                                                                                                 studies are
                                                                                                 needed.
                                4E..........  Exposure levels   ..............  Filled........  Reference range
                                               in humans                                         concentrations
                                               living near                                       are available
                                               hazardous waste                                   (Ashley et al.
                                               sites and other                                   1992, 1994;
                                               populations,                                      Needham et al.
                                               such as exposed                                   1995), and at
                                               workers.                                          least one ATSDR
                                                                                                 study that
                                                                                                 evaluated blood
                                                                                                 benzene levels
                                                                                                 and potential
                                                                                                 adverse health
                                                                                                 effects is
                                                                                                 available.
                                                                                                 ATSDR
                                                                                                 acknowledges
                                                                                                 that reference
                                                                                                 concentration
                                                                                                 data can
                                                                                                 support
                                                                                                 exposure and
                                                                                                 health
                                                                                                 assessments at
                                                                                                 waste sites,
                                                                                                 but the Agency
                                                                                                 also continues
                                                                                                 to recognize
                                                                                                 the importance
                                                                                                 of collecting
                                                                                                 additional data
                                                                                                 on uniquely
                                                                                                 exposed
                                                                                                 populations at
                                                                                                 waste sites.
Benzidine.....................  5A..........  Dose-response
                                               data for acute-
                                               and
                                               intermediate-
                                               duration
                                               exposure via
                                               the oral route
                                               (the study of
                                               intermediate-
                                               duration
                                               exposure should
                                               include
                                               evaluation of
                                               reproductive
                                               and endocrine
                                               organ
                                               histopathology,
                                               lymphoid
                                               tissues
                                               histopathology
                                               as well as
                                               examination of
                                               relevant blood
                                               components, and
                                               nervous system
                                               histopathology).
                                5B..........  Exposure levels
                                               in humans
                                               living near
                                               hazardous waste
                                               sites.
                                5C..........  Exposure levels
                                               in children.
                                5D..........  Potential         ATSDR.........
                                               candidate for
                                               subregistry of
                                               exposed persons.
Beryllium.....................  6A..........  Dose-response     EPA...........
                                               data in animals
                                               for acute- and
                                               intermediate-
                                               duration
                                               inhalation
                                               exposures. The
                                               subchronic
                                               study should
                                               include
                                               extended
                                               reproductive
                                               organ
                                               histopathology.
                                6B..........  Prenatal          EPA...........
                                               developmental
                                               toxicity study
                                               via inhalation
                                               exposure.
                                6C..........  Environmental     EPA...........
                                               fate in air;
                                               factors
                                               affecting
                                               bioavailability
                                               in air.
                                6D..........  Analytical        ..............  Filled........  Based on an
                                               methods to                                        evaluation of
                                               determine                                         the data in
                                               environmental                                     ATSDR's 2000
                                               speciation.                                       updated
                                                                                                 toxicological
                                                                                                 profile.
                                6E..........  Immunotoxicology  EPA...........
                                               battery of
                                               tests following
                                               oral exposure.

[[Page 71513]]

 
                                6F..........  Exposure levels   ..............  Filled........  Reference range
                                               in humans                                         concentrations
                                               (adults) living                                   in urine are
                                               near hazardous                                    available
                                               waste sites and                                   (Paschal et al.
                                               other                                             1998, CDC
                                               populations,                                      2005). ATSDR
                                               such as exposed                                   acknowledges
                                               workers.                                          that reference
                                                                                                 concentration
                                                                                                 data can
                                                                                                 support
                                                                                                 exposure and
                                                                                                 health
                                                                                                 assessments at
                                                                                                 waste sites,
                                                                                                 but the Agency
                                                                                                 also continues
                                                                                                 to recognize
                                                                                                 the importance
                                                                                                 of collecting
                                                                                                 additional data
                                                                                                 on uniquely
                                                                                                 exposed
                                                                                                 populations at
                                                                                                 waste sites.
                                6G..........  Exposure levels   ..............  Filled........  Reference range
                                               in children.                                      concentrations
                                                                                                 in urine are
                                                                                                 available (CDC
                                                                                                 2005).
                                6H..........  Potential         ATSDR.........
                                               candidate for
                                               subregistry of
                                               exposed persons.
Cadmium.......................  7A..........  Analytical        ..............  Filled........  Based on an
                                               methods for                                       evaluation of
                                               biological                                        the data in
                                               tissues and                                       ATSDR's 1999
                                               fluids and                                        updated
                                               environmental                                     toxicological
                                               media.                                            profile.
                                7B..........  Exposure levels   G. Lakes......  Filled........  In addition to
                                               in humans                                         the data from
                                               (adults) living                                   the Great Lakes
                                               near hazardous                                    Research
                                               waste sites and                                   Program,
                                               other                                             reference range
                                               populations,                                      concentrations
                                               such as exposed                                   in blood and
                                               workers.                                          urine are
                                                                                                 available (CDC
                                                                                                 2005), and at
                                                                                                 least nine
                                                                                                 ATSDR studies
                                                                                                 that evaluated
                                                                                                 blood and urine
                                                                                                 cadmium levels
                                                                                                 and potential
                                                                                                 adverse health
                                                                                                 effects are
                                                                                                 available.
                                7C..........  Exposure levels   ..............  Filled........  Reference range
                                               in children.                                      concentrations
                                                                                                 in blood and
                                                                                                 urine are
                                                                                                 available (CDC
                                                                                                 2005).
Carbon tetrachloride..........  8A..........  Dose-response
                                               data in animals
                                               for chronic
                                               oral exposure.
                                               The study
                                               should include

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