9 January 2009

[Federal Register: January 9, 2009 (Volume 74, Number 6)]
[Notices]               
[Page 900-902]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09ja09-38]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substances and Disease Registry

[ATSDR-249]

 
Announcement of Final Priority Data Needs for Two Priority 
Hazardous Substances

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

ACTION: Notice.

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SUMMARY: This notice announces the final 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 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 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

[[Page 901]]

(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 acrolein and barium, 
two priority substances included in the ATSDR Priority List of 
Hazardous Substances (73 FR 12178, March 6, 2008). These priority data 
needs were initially announced by ATSDR in the Federal Register on 
September 8, 2006 (71 FR 53102). The public was invited to comment on 
these data needs for these two substances during a 90-day period. No 
public comments were received. These priority data needs and 
accompanying documents were reviewed by EPA and the National Institute 
of Environmental Health Sciences (NIEHS), and 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 Two Priority
                          Hazardous Substances
------------------------------------------------------------------------
               Substance                       Priority data needs
------------------------------------------------------------------------
Acrolein...............................  Exposure levels in humans
                                          living near hazardous waste
                                          sites and other populations.
                                         Exposure levels in 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.

    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, the National 
Toxicology Program (NTP), and EPA 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 from now 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-32, Atlanta, Georgia 30333; e-mail: 
NRoney@cdc.gov. 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.

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: 
NRoney@cdc.gov; 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.
    The SSARP was initiated in 1991. A list of priority data needs for 
38 priority hazardous substances was announced for public comment in 
the Federal Register on October 17, 1991 (56 FR 52178) 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 and 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 (71 FR 53102), ATSDR released for public 
comment the priority data needs for the two hazardous substances that 
are the subject of this final notice.
    The ATSDR SSARP supplies the necessary information to improve the 
database to conduct 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 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 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, 
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 that are funded by

[[Page 902]]

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 ensure 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 two substances.
    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 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 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 Association of Minority Health Professions Schools 
(AMHPS) that supports the AMHPS Environmental Health, Health Services, 
and Toxicology Research programs.
    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.
    ATSDR encourages private-sector organizations and other 
governmental programs to use ATSDR's priority data needs to plan their 
research activities.

    Dated: January 6, 2009.
Ken Rose,
Director, Office of Policy, Planning, and Evaluation, National Center 
for Environmental Health/Agency for Toxic Substances and Disease 
Registry.
 [FR Doc. E9-189 Filed 1-8-09; 8:45 am]

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