E9-25776. Announcement of Final Priority Data Needs for Six Priority Hazardous Substances

AGENCY:

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

ACTION:

Notice.

SUMMARY:

This notice announces the final 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). This 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 information essential to improving 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 six hazardous substances.

The priority data needs announced 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), 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.

Table 1 presents the priority data needs for six priority substances included in the ATSDR Priority List of Hazardous Substances (73 FR 12178, March 6, 2008). ATSDR initially announced these priority data needs in the Federal Register on December 28, 2007 (72 FR 73828), and the public had 90 days to comment on them. EPA, the National Institute of Environmental Health Sciences (NIEHS)/National Toxicology Program (NTP), the National Institute for Occupational Safety and Health (NIOSH), and the U.S. Food and Drug Administration/National Center for Toxicological Research (FDA/NCTR) reviewed the six priority data needs and accompanying documents. The mechanisms described in the “Implementation of Substance-Specific Applied Research Program” section of this Federal Register Notice will address these data needs.

Table 1—Substance-Specific Priority Data Needs for Six Priority Hazardous Substances

Substance	Priority data needs
Aluminum	Exposure levels in humans living near hazardous waste sites.
	Exposure levels in children.
	Exposure levels for adults and children who do not live near hazardous waste sites (as controls).
	Dose-response data for acute-duration 1 oral exposure.
Cresol	Exposure levels in humans living near hazardous waste sites.
	Exposure levels in children.
	Dose-response data for acute-duration 1 oral exposure.
Diazinon	Developmental toxicity data for oral exposure.
Dichloropropenes	Dose-response data for acute-duration 1 inhalation exposure.
	Immunotoxicity battery via inhalation exposure.
Guthion	Studies of developmental toxicity via oral exposure, with emphasis on neurodevelopmental toxicity.
Phenol	Exposure levels in humans living near hazardous waste sites.
	Exposure levels in children.
1 14 days or less.

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, available on ATSDR's Web site at http://www.atsdr.cdc.gov/​pdns/​. Printed copies are also available by written request from ATSDR (see ADDRESSES section of this notice).

Voluntary Research. 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 submitting 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, NTP, EPA, FDA, and NIOSH, will review all proposals.

DATES:

The ATSDR voluntary research program is a continuous program, and private-sector organizations can volunteer to fill identified data needs until ATSDR announces that other research has been initiated for a specific data need.

ADDRESSES:

The priority data needs are available on ATSDR's Web site at http://www.atsdr.cdc.gov/​pdns/​. Private-sector organizations interested in volunteering to conduct research to fill identified priority data needs should write to Nickolette Roney, Applied Toxicology Branch, Division of Toxicology and Environmental Medicine, ATSDR, 1600 Clifton Road, NE., Mailstop F-62, Atlanta, GA 30333; e-mail: [e-mail]. Use the same address for sending information about pertinent ongoing or completed research that may fill priority data needs cited in this notice and for requesting printed copies of the priority data needs documents.

FOR FURTHER INFORMATION CONTACT:

Nickolette Roney, Applied Toxicology Branch, Division of Toxicology and Environmental Medicine, ATSDR, 1600 Clifton Road, NE., Mailstop F-62, Atlanta, GA 30333; e-mail: [e-mail]; telephone: [phone]; fax: [phone].

SUPPLEMENTARY INFORMATION:

Background

CERCLA, as amended by SARA [42 U.S.C. 9604(i)], requires that ATSDR (1) develop jointly with EPA a list of hazardous substances (in order of priority) found at National Priorities List (NPL) sites, (2) prepare toxicological profiles of these substances, and (3) ensure the initiation of a research program to address identified priority data needs associated with the substances.

The SSARP was initiated in 1991. On November 16, 1992 (57 FR 54150), priority data needs for 38 priority hazardous substances were published in the Federal Register in final form, after release for public comment. On July 30, 1997 (62 FR 40820), after releasing for public comment, ATSDR finalized the priority data needs for a second list of 12 substances. ATSDR identified priority data needs for a third list of 10 hazardous substances, published in its final form on April 29, 2003 (68 FR 22704), after release for public comment. On January 9, 2009 (74 FR 900), priority data needs for two hazardous substances were published in final form after release for public comment. On December 28, 2007 (72 FR 73828), ATSDR released for public comment the priority data needs for the six hazardous substances that are the subject of this final notice.

ATSDR SSARP supplies the necessary information to improve the database for conducting public health assessments. The link between research and public health assessments and the process for distilling priority data needs from the 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 the Substance-Specific Applied Research Program

In Section 104(i)(5)(D), CERCLA states that Congress believes the costs for conducting this research program should be borne by the manufacturers and processors of the hazardous substances under the Toxic Substances Control Act of 1976 (TSCA); 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 SSARP are being conducted through 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, established under Section 4(e) of TSCA, for the types of research to be done. ATSDR actively participates on this committee. Federally funded projects that collect information from 10 or more respondents and 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 is research involving human subjects, the applicants must comply with Department of Health and Human Services regulations (45 CFR part 46) and, if applicable, Food and Drug Administration regulations (21 CFR parts 50 and 56), regarding the protection of human subjects. The applicants must ensure that the project will be subject to initial and continuing review by the appropriate institutional review boards. Overall, by providing additional scientific information for the risk assessment process, data generated from this research will support other researchers conducting human health assessments involving these substances.

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

A. TSCA/FIFRA

In developing and implementing SSARP, ATSDR and EPA established procedures to identify 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 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 submitting 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. TASARC will review these proposals and recommend to ATSDR the voluntary research projects that 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 not addressed by TSCA/FIFRA or initial voluntarism will be considered for funding by ATSDR through its CERCLA budget. Much 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.

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

ATSDR encourages private-sector organizations and other governmental programs to use ATSDR's priority data needs to plan their research activities.

Dated: October 21, 2009.

Ken Rose,

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