Agency for Toxic Substances and Disease Registry September 2006 – Federal Register Recent Federal Regulation Documents

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).