Identification Of Priority Data Needs for Six Priority Hazardous Substances, 73828-73830 [E7-25213]
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Federal Register / Vol. 72, No. 248 / Friday, December 28, 2007 / Notices
Conference Center, 9751 Washingtonian
Blvd., Gaithersburg, MD 20878.
Contact Person: Anyone wishing to
obtain a roster of members, agenda or
minutes of the non-confidential portions
of this meeting should contact Mrs.
Bonnie Campbell, Committee
Management Officer, Office of
Extramural Research, Education and
Priority Populations, AHRQ, 540
Gaither Road, Room 2038, Rockville,
Maryland 20850, Telephone (301) 427–
1554.
Agenda items for this meeting are
subject to change as priorities dictate.
Dated: December 19, 2007.
Carolyn M. Clancy,
Director.
[FR Doc. 07–6216 Filed 12–27–07; 8:45 am]
BILLING CODE 4160–90–M
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 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.
AGENCY:
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
Substance
Priority data needs
Aluminum ...........................................................................
Cresol .................................................................................
mstockstill on PROD1PC66 with NOTICES
Diazinon .............................................................................
Dichloropropenes ...............................................................
Guthion ...............................................................................
Phenol ................................................................................
(1) 14
Exposure levels in humans living near hazardous waste sites.
Exposure levels in children.
Dose-response data for acute-duration(1) oral exposure.
Exposure levels in humans living near hazardous waste sites.
Exposure levels in children.
Dose-response data for acute-duration(1) oral exposure.
Developmental toxicity data for oral exposure.
Dose-response data for acute-duration(1) inhalation exposure.
Immunotoxicity battery via inhalation exposure.
Studies of developmental toxicity via oral exposure
neurodevelopmental toxicity.
Exposure levels in humans living near hazardous waste sites.
Exposure levels in children.
Two-year oral carcinogenicity bioassay.
days or less.
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with
emphasis
on
Federal Register / Vol. 72, No. 248 / Friday, December 28, 2007 / Notices
mstockstill on PROD1PC66 with NOTICES
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 TriAgency 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
https://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, privatesector 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 https://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
VerDate Aug<31>2005
22:27 Dec 27, 2007
Jkt 214001
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.
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73829
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, peerreviewed scientific work. Additional
details regarding the process for
voluntary research are in the Federal
Register Notices cited in this section.
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Federal Register / Vol. 72, No. 248 / Friday, December 28, 2007 / Notices
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–222 and CMS–
R–268]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services, HHS.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Centers for Medicare & Medicaid
Services (CMS) is publishing the
following summary of proposed
collections for public comment.
Interested persons are invited to send
comments regarding this burden
estimate or any other aspect of this
collection of information, including any
of the following subjects: (1) The
necessity and utility of the proposed
information collection for the proper
mstockstill on PROD1PC66 with NOTICES
AGENCY:
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22:27 Dec 27, 2007
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performance of the agency’s functions;
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (4) the use of
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
1. Type of Information Collection
Request: Extension of currently
approved collection; Title of
Information Collection: Independent
Rural Health Center/Freestanding
Federally Qualified Health Center Cost
Report and Supporting Regulations 42
CFR 413.20 AND 42 CFR 413.24; Use:
Providers of service in the Medicare
program are required to submit annual
information to achieve reimbursement
for health care services rendered to
Medicare beneficiaries. The Form CMS–
222 cost report is needed to determine
the amount of reasonable cost due to the
providers for furnishing medical
services to Medicare beneficiaries; Form
Number: CMS–222 (OMB# 0938–0107);
Frequency: Yearly; Affected Public:
Business or other for-profit and Not-forprofit institutions; Number of
Respondents: 3,159; Total Annual
Responses: 3,159; Total Annual Hours:
157,950.
2. Type of Information Collection
Request: Revision of currently approved
collection; Title of Information
Collection: Survey Tool for https://
www.medicare.gov and https://
www.cms.hhs.gov; Use: The purpose of
this submission is to request a revision
of 0938–0756 (CMS-R–268) to continue
to collect information from Internet
users as they exit from the Websites
Medicare.gov and CMS.hhs.gov. As part
of the revised collection we are
combining the content from the
collection 0938–0900 that was
discontinued on 5/31/2007. The
packages are being combined to
eliminate a duplication of effort. We are
requesting a three-year clearance, so that
the feedback received through the
survey can be used continually to
update and improve the sites. To ensure
that we gather information about user
reactions to the Websites, we have
developed a survey tool that users can
complete when they exit either site or
by accessing a link on the bottom bar on
the page. The responses on this survey
tool will help CMS to make appropriate
changes to the Websites in the future.
The survey tool contains questions
about the information that visitors are
seeking from the sites, the degree to
which either site was useful to them, the
improvements that they would like to
see in the sites, and their general
comments. Form Number: CMS–R–268
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(OMB# 0938–0756); Frequency: On
occasion; Affected Public: Individuals
and households, Private sector—
Business or other for-profit; Number of
Respondents: 7,000; Total Annual
Responses: 7,000; Total Annual Hours:
1,167.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS’ Web Site
address at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786–
1326.
To be assured consideration,
comments and recommendations for the
proposed information collections must
be received at the address below, no
later than 5 p.m. on February 26, 2008.
CMS, Office of Strategic Operations and
Regulatory Affairs, Division of
Regulations Development—C, Attention:
Bonnie L Harkless, Room C4–26–05,
7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
Dated: December 20, 2007.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E7–25289 Filed 12–27–07; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–7007–N]
Medicare Program; Request for
Nominations for the Advisory Panel on
Medicare Education
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
AGENCY:
SUMMARY: This notice requests
nominations for individuals to serve on
the Advisory Panel on Medicare
Education (the Panel) to fill current
vacancies and vacancies that will
become available in 2008. The Panel
advises and makes recommendations to
the Secretary of Health and Human
Services and the Administrator of the
Centers for Medicare & Medicaid
Services on the effectiveness of
consumer education strategies
concerning the Medicare program.
E:\FR\FM\28DEN1.SGM
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]]>Agencies
[Federal Register Volume 72, Number 248 (Friday, December 28, 2007)]
[Notices]
[Pages 73828-73830]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-25213]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
------------------------------------------------------------------------
Substance Priority data needs
------------------------------------------------------------------------
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.
------------------------------------------------------------------------
\(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 https://
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 https://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
