Agency for Toxic Substances and Disease Registry – Federal Register Recent Federal Regulation Documents

This notice announces the availability of an Update to the ATSDR Policy Guideline for Dioxins and Dioxin-Like Compounds in Residential Soil at: https://www.atsdr.cdc.gov/toxpro2.html and https:// www.atsdr.cdc.gov/substances/dioxin/policy.

This notice announces the development of Set 22 Toxicological Profiles. Set 22 Toxicological Profiles consists of one new draft and five updated drafts. These profiles will be available to the public for comment on or about October 17, 2008.

This notice announces the availability of two interaction profiles prepared by ATSDR for public comments [draft documents].

This notice announces the availability of seven updated final toxicological profiles of priority hazardous substances. This is the 19th set of toxicological profiles that ATSDR has compiled.

This notice makes available for public comment the priority data needs for six priority hazardous substances (see Table 1) as part of the continuing development and implementation of the ATSDR Substance-Specific Applied Research Program (SSARP). The notice also serves as a continuous call for voluntary research proposals. The exposure and toxicity priority data needs in this notice were distilled from the data needs identified in ATSDR's toxicological profiles by the logical scientific approach described in a decision guide published in the Federal Register on September 11, 1989 (54 FR 37618). The priority data needs represent essential information to improve the database for conducting public health assessments. Research to address these priority data needs will help to determine the types or levels of exposure that may present significant risks of adverse health effects in people exposed to the hazardous substances. The priority data needs identified in this notice reflect the opinion of ATSDR, in consultation with other federal programs, about the research needed pursuant to ATSDR's authority under the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (Superfund), or CERCLA, as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA) [42 U.S.C. 9604(i)]. The needs identified here do not represent the priority data needs for any other agency or program. Consistent with Section 104(i)(12) of CERCLA as amended [42 U.S.C. 9604(i)(12)], nothing in this research program shall be construed to delay or otherwise affect or impair the President, the Administrator of ATSDR, or the Administrator of the Environmental Protection Agency (EPA) from exercising any authority regarding any other provision of law, including the Toxic Substances Control Act of 1976 (TSCA) and the Federal Insecticide, Fungicide, and Rodenticide Act of 1972 (FIFRA), or the response and abatement authorities of CERCLA. ATSDR worked with other federal programs to determine common substance-specific data needs and mechanisms to implement research that may include authorities under TSCA and FIFRA, private-sector voluntarism, or the direct use of CERCLA funds. When deciding the type of research that should be done, ATSDR considers the recommendations of the Interagency Testing Committee (ITC) established under Section 4(e) of TSCA. Federally funded projects that collect information from 10 or more respondents and that are funded by cooperative agreements are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act. If the proposed project involves research on human subjects, the applicants must comply with Department of Health and Human Services regulations (45 CFR part 46) regarding the protection of human subjects. The applicants must assure that the project will be subject to initial and continuing review by the appropriate institutional review committees. Overall, by providing additional scientific information for the risk assessment process, data generated from this research will support other researchers who are conducting human health assessments involving these six substances. Table 1 presents the priority data needs for six priority substances. The six substances are included in the ATSDR Priority List of Hazardous Substances (70 FR 72840, December 7, 2005). ATSDR invites comments from the public on the individual priority data needs and the priority data needs documents for these substances. After considering the comments, ATSDR will publish the final priority data needs for each substance. These priority data needs will be addressed by the mechanisms described in the ``Implementation of Substance-Specific Applied Research Program'' section of this Federal Register Notice.

The Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA), as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA), section 104(i)(3) [42 U.S.C. 9604(i)(3)] directs the Administrator of ATSDR to prepare toxicological profiles of priority hazardous substances and to revise and publish each updated toxicological profile as necessary. This notice announces the availability of the 21st set of toxicological profiles, which consists of one new draft and six updated drafts, prepared by ATSDR for review and comment.

This notice announces the intent of ATSDR to develop two interaction profiles.

This notice announces those sites for which ATSDR has completed public health assessments and health consultations during the period from January 1, 2007 through March 31, 2007. This list includes sites that are on or proposed for inclusion on the National Priorities List (NPL) and includes sites for which assessments or consultations were prepared in response to requests from the public.

ATSDR is seeking public comment on the draft revision of its 1998 Policy Guideline for Dioxins and Dioxin-Like Compounds in Residential Soil. The policy is intended to assist health assessors who must evaluate the public health implications of dioxin and dioxin-like compounds (e.g., 2,3,7,8-tetrachlorodibenzo-p-dioxin [TCDD], chlorinated dibenzodioxins [CDDs], chlorinated dibenzofurans [CDFs], and other structurally related groups of chemicals from the family of halogenated aromatic hydrocarbons) in residential soils near or on hazardous waste sites. The 1998 policy established a screening level of 0.05 ppb TEQ (50 ppt), an evaluation level (>0.05 ppb TEQ,

This notice announces the availability of one new and five updated final toxicological profiles of priority hazardous substances comprising the eighteenth set prepared by ATSDR.

This notice makes available for public comment the priority data needs for two priority hazardous substances (see Table 1) as part of the continuing development and implementation of the ATSDR Substance-Specific Applied Research Program (SSARP). The notice also serves as a continuous call for voluntary research proposals. The SSARP is authorized by the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (Superfund) or CERCLA, as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA) [42 U.S.C. 9604(i)]. This research program was initiated in 1991. At that time, a list of priority data needs for 38 priority hazardous substances was announced in the Federal Register on October 17, 1991 (56 FR 52178). The list was subsequently revised, based on public comments, and published in final form on November 16, 1992 (57 FR 54150). In 1997, ATSDR finalized the priority data needs for a second list of 12 substances; that priority data needs list was subsequently announced in the Federal Register on July 30, 1997 (62 FR 40820). Ten substances constitute the third list of hazardous substances for which priority data needs were identified by ATSDR. The final list of the 10 substances was published on April 29, 2003 (68 FR 22704), after it was subjected to public comment. The exposure and toxicity priority data needs in this notice were distilled from data needs identified in the Agency's toxicological profiles via a logical scientific approach described in a ``Decision Guide'' published in the Federal Register on September 11, 1989 (54 FR 37618). The priority data needs represent essential information to improve the database for conducting public health assessments. Research to address these priority data needs will help determine the types or levels of exposure that may present significant risks of adverse health effects in people exposed to the hazardous substances. The priority data needs identified in this notice reflect the opinion of the Agency, in consultation with other Federal programs, of the research needed pursuant to ATSDR's authority under CERCLA. They do not represent the priority data needs for any other agency or program. Consistent with Section 104(i)(12) of CERCLA as amended [42 U.S.C. 9604(i)(12)], nothing in this research program shall be construed to delay or otherwise affect or impair the authority of the President, the Administrator of ATSDR, or the Administrator of EPA to exercise any authority regarding any other provision of law, including the Toxic Substances Control Act of 1976 (TSCA) and the Federal Insecticide, Fungicide, and Rodenticide Act of 1972 (FIFRA), or the response and abatement authorities of CERCLA. In developing this research program, ATSDR has worked with other federal programs to determine common substance-specific data needs, as well as mechanisms to implement research that may include authorities under TSCA and FIFRA, private-sector voluntarism, or the direct use of CERCLA funds. When deciding the type of research that should be done, ATSDR considers the recommendations of the Interagency Testing Committee established under Section 4(e) of TSCA. Federally funded projects that collect information from 10 or more respondents and that are funded by cooperative agreements are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act. If the proposed project involves research on human subjects, the applicants must comply with Department of Health and Human Services regulations (45 CFR part 46) regarding the protection of human subjects. Assurance must be provided that the project will be subject to initial and continuing review by the appropriate institutional review committees. Overall, data generated from this research program will lend support to others conducting human health assessments involving these two substances by providing additional scientific information for the risk assessment process. The two substances that are included in the ATSDR Priority List of Hazardous Substances established by ATSDR and EPA (70 FR 72840, December 7, 2005) are: Acrolein Barium The priority data needs for these two substances are presented in Table 1. We invite comments from the public on individual priority data needs. After considering the comments, ATSDR will publish the final priority data needs for each substance. These priority data needs will be addressed by the mechanisms described in the ``Implementation of Substance-Specific Applied Research Program'' section of this Federal Register 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 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) comprised of scientists from ATSDR, the National Toxicology Program (NTP), and EPA, will review all proposals. The substance-specific priority data needs were based on, and determined from, information in corresponding ATSDR toxicological profiles. Background technical information and justification for the priority data needs in this notice are in the priority data needs documents. These documents are available for review by requesting them in writing from ATSDR (see ADDRESSES section of this notice).

This notice announces the development of Set 20 Toxicological Profiles. Set 20 Toxicological Profiles consists of one new draft and six updated drafts. These profiles will be available to the public on or about October 17, 2006.

This notice announces those sites for which ATSDR has completed public health assessments during the period from January 2006 through March 2006. This list includes sites that are on or proposed for inclusion on the National Priorities List (NPL) and includes sites for which assessments were prepared in response to requests from the public.

This notice announces the availability of one new and seven updated final toxicological profiles of priority hazardous substances comprising the seventeenth set prepared by ATSDR.

The Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA or Superfund), as amended by the Superfund Amendments and Reauthorization Act (SARA), requires that ATSDR and the Environmental Protection Agency (EPA) revise the Priority List of Hazardous Substances. This list includes substances most commonly found at facilities on the CERCLA National Priorities List (NPL) which have been determined to be of greatest concern to public health at or around these NPL hazardous waste sites. This announcement provides notice that the agencies have developed and are making available a revised CERCLA Priority List of 275 Hazardous Substances, based on the most recent information available. Each substance on the priority list is a candidate to become the subject of a toxicological profile prepared by ATSDR and subsequently a candidate for the identification of priority data needs. In addition to the Priority List of Hazardous Substances, ATSDR has developed a Completed Exposure Pathway Site Count Report. This report lists the number of sites or events with ATSDR activities where a substance has been found in a completed exposure pathway (CEP). This report is included in the Support Document of the Priority List.

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 (PAHsincludes 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.

The Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA), as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA), Section 104(i)(3) [42 U.S.C. 9604(i)(3)] directs the Administrator of ATSDR to prepare toxicological profiles of priority hazardous substances and to revise and publish each updated toxicological profile as necessary. This notice announces the availability of the 19th set of toxicological profiles, which consists of one new draft and seven updated drafts, prepared by ATSDR for review and comment.

This notice announces those sites for which ATSDR has completed public health assessments during the period from April through June 2005. This list includes sites that are on or proposed for inclusion on the National Priorities List (NPL) and includes sites for which assessments were prepared in response to requests from the public.

This notice announces those sites for which ATSDR has completed public health assessments during the period from January through March 2005. This list includes sites that are on or proposed for inclusion on the National Priorities List (NPL) and includes sites for which assessments were prepared in response to requests from the public.

This notice announces the availability of the ATSDR Public Health Assessment Guidance Manual (Update). ATSDR is mandated to conduct public health assessment activities at all sites on, or proposed for inclusion on, the National Priorities List (NPL). ATSDR can also conduct public health assessments in response to a request from the public for an evaluation of active waste sites, landfills, and other possible releases of hazardous substances to the environment.