[Federal Register: December 28, 2007 (Volume 72, Number 248)]
[Notices]
[Page 73828-73830]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28de07-108]
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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.
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\(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: 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 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:
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.
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.
[[Page 73830]]
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