[Federal Register Volume 71, Number 174 (Friday, September 8, 2006)]
[Notices]
[Pages 53102-53104]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-14870]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substances and Disease Registry

[ATSDR-223]


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.

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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

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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: 
[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 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: (770) 488-3325, fax: (770) 488-4178.

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

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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
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          Substance                       Priority data needs
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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.
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(1) 365 days or more.
(2) 14 days or less.

 [FR Doc. E6-14870 Filed 9-7-06; 8:45 am]
BILLING CODE 4163-70-P