[Federal Register Volume 72, Number 248 (Friday, December 28, 2007)]
[Notices]
[Pages 73828-73830]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-25213]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substances and Disease Registry

[ATSDR-237]


Identification Of 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: Request for public comments on the identification of priority 
data needs for six priority hazardous substances and an ongoing call 
for voluntary research proposals.

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SUMMARY: 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.

    Table 1.--Substance-Specific Priority Data Needs for Six Priority
                          Hazardous Substances
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             Substance                       Priority data needs
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Aluminum..........................  Exposure levels in humans living
                                     near hazardous waste sites.
                                    Exposure levels in children.
                                    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.
                                    Two-year oral carcinogenicity
                                     bioassay.
------------------------------------------------------------------------
\(1)\ 14 days or less.



[[Page 73829]]

    Note: Consult the priority data needs documents for details on 
how these priority data needs were determined.

    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, 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 on ATSDR's Web site at http://www.atsdr.cdc.gov/pdns/. Printed copies of these documents are also 
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 six 
substances must be received by 90 days from the publication date. 
Regarding ATSDR's call for voluntary research proposals, the agency 
considers voluntary research crucial to the continuing development of 
SSARP 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 until 
ATSDR announces that other research has been initiated for a specific 
priority data need.

ADDRESSES: The priority data needs documents are available on ATSDR's 
Web site at http://www.atsdr.cdc.gov/pdns/. Submit comments to 
Nickolette Roney, Applied Toxicology Branch, Division of Toxicology and 
Environmental Medicine, ATSDR, 1600 Clifton Road, NE., Mailstop F-32, 
Atlanta, Georgia 30333; e-mail: [email protected]. 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 to request printed copies of the priority data needs 
documents and to submit proposals to conduct voluntary research.

FOR FURTHER INFORMATION CONTACT: Nickolette Roney, Applied Toxicology 
Branch, Division of Toxicology and Environmental Medicine, ATSDR, 1600 
Clifton Road, NE., Mailstop F-32, Atlanta, Georgia 30333; e-mail: 
[email protected]; telephone: (770) 488-3332; fax: (770) 488-4178.

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 found at 
National Priorities List (NPL) sites (in order of priority), (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.
    SSARP was initiated in 1991. 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 was published in final form on November 
16, 1992 (57 FR 54150). In 1997, after releasing for public comment, 
ATSDR finalized the priority data needs for a second list of 12 
substances that priority data needs list was announced in the Federal 
Register on July 30, 1997 (62 FR 40820). ATSDR then identified priority 
data needs for a third list of 10 hazardous substances; this list was 
released as a draft for public comment and published in its final form 
on April 29, 2003 (68 FR 22704). On September 8, 2006, ATSDR released 
priority data needs for two hazardous substances as a draft for public 
comment (71 FR 53102).
    This ATSDR SSARP supplies the 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 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 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 should be 
borne by the manufacturers and processors of the hazardous substances 
found 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, 
on the types of research to be done. ATSDR actively participates on 
this committee.
    The mechanisms for implementing SSARP are discussed next. 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 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 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.

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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. 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. 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

    Table 1 identifies the priority data needs. ATSDR encourages 
private-sector organizations and other governmental programs to use 
ATSDR's priority data needs to plan their research activities.

    Dated: December 19, 2007.
Ken Rose,
Director, Office of Policy, Planning and Evaluation, National Center 
for Environmental Health/Agency for Toxic Substances and Disease 
Registry.
[FR Doc. E7-25213 Filed 12-27-07; 8:45 am]
BILLING CODE 4163-70-P