E6-14870. Identification of Priority Data Needs for Two Priority Hazardous Substances

AGENCY:

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

ACTION:

Request for public comments on the identification of priority data needs for two priority hazardous substances, and an ongoing call for voluntary research proposals.

SUMMARY:

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).

DATES:

Comments concerning the priority data needs for the two substances must be received by December 5, 2006. Regarding ATSDR's call for voluntary research proposals, the Agency considers the voluntary research effort to be crucial to the continuing development of the Substance-Specific Applied Research Program and believes this effort should be an open and continuous one. Therefore, private-sector organizations are encouraged to volunteer to conduct research to address the identified priority data needs, beginning with the publication of this notice and until that time when ATSDR announces that other research has been initiated for a specific priority data need.

ADDRESSES:

Submit comments 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: [e-mail]. Information about pertinent ongoing or completed research that may fill priority data needs cited in this notice should be similarly addressed. Also, use the same address for requests for priority data needs documents and submission of proposals to conduct voluntary research.

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: [phone], fax: [phone].

SUPPLEMENTARY INFORMATION:

Background

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)], requires that ATSDR (1) develop jointly with EPA a list of hazardous substances found at National Priorities List (NPL) sites (in order of priority), (2) prepare toxicological profiles of these substances, and (3) assure the initiation of a research program to address identified priority data needs associated with the substances.

The Substance-Specific Applied Research Program (SSARP) 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 and announced the list 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 was published in the Federal Register on April 29, 2003 (68 FR 22704) after it was subjected to public comment.

This ATSDR SSARP supplies necessary information to improve the database to conduct public health assessments. This link between research and public health assessments, and the process for distilling priority data needs for ranked hazardous substances from data needs identified in associated ATSDR toxicological profiles, are described in the ATSDR “Decision Guide for Identifying Substance-Specific Data Needs Related to Toxicological Profiles” (54 FR 37618, September 11, 1989).

Implementation of Substance-Specific Applied Research Program

In Section 104(i)(5)(D), CERCLA 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 substances under the Toxic Substances Control Act of 1976 (TSCA) and by registrants under the Federal Insecticide, Fungicide, and Rodenticide Act of 1972 (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 regulatory mechanisms (TSCA/FIFRA), private-sector voluntarism, and the direct use of CERCLA funds.

CERCLA also requires that ATSDR consider recommendations of the Interagency Testing Committee (ITC), established under Section 4(e) of TSCA, on the types of research to be done. ATSDR actively participates on this committee. Acrolein was added to the Priority Testing List in the ITC 27th Report in 1990, but barium has never been added to the Priority Testing List.

The mechanisms for implementing the SSARP are discussed next. The status of the SSARP in addressing priority data needs of the first 60 priority hazardous substances via these mechanisms was described in a Federal Register notice on December 13, 2005 (70 FR 73749).

A. TSCA/FIFRA

In developing and implementing the SSARP, ATSDR and EPA established procedures to identify those priority data needs of common interest to multiple Federal programs. Where practicable, these data needs will be addressed through a program of toxicologic testing under TSCA or FIFRA. This part of the research will be conducted according to established TSCA/FIFRA procedures and guidelines.

B. Private-Sector Voluntarism

As part of the SSARP, on February 7, 1992, ATSDR announced a set of proposed procedures for conducting voluntary research (57 FR 4758). Revisions based on public comments were published on November 16, 1992 (57 FR 54160). ATSDR strongly encourages private-sector organizations to propose research to address priority data needs at any time until ATSDR announces that research has already been initiated for a specific priority data need. 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.

The letter of intent should be a brief statement (1-2 pages) that identifies the priority data need(s) to be filled and the methods to be used. The Tri-Agency Superfund Applied Research Committee (TASARC) will review these proposals and make recommendations to ATSDR regarding which specific voluntary research projects should be pursued—and how they should be conducted—with the volunteer organizations. ATSDR will enter into only those voluntary research projects that lead to high quality, peer-reviewed scientific work. Additional details regarding the process for voluntary research are in the Federal Register notices cited in this section.

C. CERCLA

Those priority data needs that are not addressed by TSCA/FIFRA or initial voluntarism will be considered for funding by ATSDR through its CERCLA budget. A large part of this research program is envisioned to be unique to CERCLA—for example, research on substances not regulated by other programs or research needs specific to public health assessments. A current example of the direct use of CERCLA funds is a cooperative agreement with the Minority Health Professions Foundation (MHPF) that supports the MHPF's Environmental Health, Health Services and Toxicology Research Program.

Mechanisms to address these priority data needs may include a second call for voluntarism. Again, scientific peer review of study protocols and results would occur for all research conducted under this auspice.

Substance-Specific Priority Data Needs

The priority data needs are identified in Table 1. Specifically, for acrolein, three priority data needs have been identified, while one priority data need was identified for barium. ATSDR encourages private-sector organizations and other governmental programs to use ATSDR's priority data needs to plan their research activities.

Dated: September 1, 2006.

Kenneth Rose,

Acting Director, Office of Policy, Planning, and Evaluation, National Center for Environmental Health/Agency for Toxic Substances and Disease Registry.

Table 1.—Substance-Specific Priority Data Needs (PDN) for Fourth Set of Two Priority Hazardous Substances

Substance	Priority data needs
Acrolein	Exposure levels in humans living near hazardous waste sites.
	Exposure levels of children.
	Dose-response data for chronic-duration(1) via inhalation exposure.
Barium	Dose-response data for acute-duration(2) via oral exposure.
(1) 365 days or more.
(2) 14 days or less.