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Identification of Priority Data Needs for Two Priority Hazardous Substances
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: September 8, 2006 (Volume 71, Number 174)]
[Notices]
[Page 53102-53104]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08se06-54]
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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
[[Page 53103]]
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:
YStevens@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 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
[[Page 53104]]
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