[Federal Register Volume 74, Number 206 (Tuesday, October 27, 2009)]
[Notices]
[Pages 55240-55242]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-25776]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substances and Disease Registry

[ATSDR-255]


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.

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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

[[Page 55241]]

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
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                            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.
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\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: [email protected]. 
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: 
[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 (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

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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.
[FR Doc. E9-25776 Filed 10-26-09; 8:45 am]
BILLING CODE 4163-70-P