[Federal Register: December 13, 2005 (Volume 70, Number 238)]
[Notices]
[Page 73749-73773]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13de05-52]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Toxic Substances and Disease Registry
[ATSDR-215]
Update on the Status of the Superfund Substance-Specific Applied
Research Program
Editorial Note: FR Doc. 05-23361 was originally published at
page 71506 in the issue of Tuesday, November 29, 2005. The corrected
document is republished below in its entirety, due to printing
errors.
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 provides the status of ATSDR's Superfund-mandated
Substance-Specific Applied Research Program (SSARP) which was last
updated in a Federal Register notice in 2002 (67 FR 4836). Authorized
by the Comprehensive Environmental Response, Compensation, and
Liability Act of 1980 (CERCLA, also known as the Superfund statute), as
amended by the Superfund Amendments and Reauthorization Act of 1986
(SARA) [42 U.S.C. 9604 (i)], this research program was initiated on
October 17, 1991. At that time, a list of priority data needs for 38
priority hazardous substances frequently found at waste sites was
announced in the Federal Register (56 FR 52178). The list was
subsequently revised based on public comments and published in final
form on November 16, 1992 (57 FR 54150).
The 38 substances, each of which is found on ATSDR's Priority List
of Hazardous Substances (68 FR 63098, November 7, 2003), are aldrin/
dieldrin, arsenic, benzene, beryllium, cadmium, carbon tetrachloride,
chloroethane, chloroform, chromium, cyanide, p,p'-DDT,DDE,DDD, di(2-
ethylhexyl) phthalate, lead, mercury, methylene chloride, nickel,
polychlorinated biphenyl compounds (PCBs), polycyclic aromatic
hydrocarbons (PAHs--includes 15 substances), selenium,
tetrachloroethylene, toluene, trichloroethylene, vinyl chloride, and
zinc.
On July 30, 1997, priority data needs for 12 additional hazardous
substances frequently found at waste sites were determined and
announced in the Federal Register (62 FR 40820). The 12 substances,
each of which is included in ATSDR's Priority List of Hazardous
Substances, are chlordane, 1,2-dibromo-3-chloropropane, di-n-butyl
phthalate, disulfoton, endrin (includes endrin aldehyde), endosulfan
(alpha-, beta-, and endosulfan sulfate), heptachlor (includes
heptachlor epoxide), hexachlorobutadiene, hexachlorocyclohexane (alpha-
, beta-, delta- and gamma-), manganese, methoxychlor, and toxaphene.
More recently, priority data needs for 10 additional hazardous
substances frequently found at waste sites were determined and
announced in the Federal Register (68 FR 22704). The ten substances,
each of which is included in ATSDR's Priority List of Hazardous
Substances, are asbestos, benzidine, chlorinated dibenzo-p-dioxins,
1,2-dibromoethane, 1,2-dichloroethane, 1,1-dichloroethene,
ethylbenzene, pentachlorophenol, 1,1,2,2-tetrachloroethane, and total
xylenes.
Currently, the priority data needs for acrolein and barium are
being identified and will be reported in a future Federal Register
notice.
To date, 270 priority data needs have been identified for the 60
hazardous substances, and 86 priority data needs have been filled
(Table 1). ATSDR fills these research needs through U.S. Environmental
Protection Agency (EPA) regulatory mechanisms (test rules), private-
sector voluntarism, and the direct use of CERCLA funds. Additional
priority data needs are being addressed through collaboration with the
National Toxicology Program (NTP), by ATSDR's Great Lakes Human Health
Effects Research Program, and other Agency programs. Priority data
needs documents describing ATSDR's rationale for prioritizing research
needs for each substance are available. See ADDRESSES section of this
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 identified 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) composed of scientists
from ATSDR, National Institute of Environmental Health Sciences
(NIEHS)/NTP, and the EPA, will review all proposed voluntary research
studies.
DATES: ATSDR provides updates on the status of its Substance-Specific
Applied Research Program approximately every three years or sooner, as
needed. ATSDR considers the voluntary research effort to be important
to the continuing implementation of the SSARP. Therefore, the Agency
strongly encourages private-sector organizations to volunteer at any
time to conduct research to fill data needs until ATSDR announces that
other research mechanisms are in place to address those specific data
needs.
ADDRESSES: Private-sector organizations interested in volunteering to
conduct research can write 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.
Other Requirements: Projects that involve the collection of
information from ten or more individuals and funded by cooperative
agreement will be subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act.
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
CERCLA as amended by SARA [42 U.S.C. 9604(i)] requires that ATSDR
(1) jointly with the EPA, develop and
[[Page 73750]]
prioritize a list of hazardous substances found at National Priorities
List (NPL) sites, (2) prepare toxicological profiles for these
substances, and (3) assure the initiation of a research program, in
conjunction with NTP, to address identified data needs associated with
the substances. Before starting such a program, ATSDR will consider
recommendations of the InterAgency Testing Committee on the type of
research that should be done. This committee was established under
section 4(e) of the Toxic Substances Control Act of 1976 [15 U.S.C.
2604(e)](TSCA).
The major goals of the ATSDR SSARP are (1) to address the
substance-specific information needs of the public and scientific
community, and (2) to supply information necessary to improve the
database used to conduct comprehensive public health assessments of
populations living near hazardous waste sites. We anticipate that the
information will help to establish linkages between levels of
contaminants in the environment and levels in human tissue and organs
associated with adverse health effects. Once such links have been
established, strategies to mitigate potentially harmful exposures can
be developed. This program will also provide data that can be
generalized to other substances or areas of science, including risk
assessment of chemicals, thus creating a scientific information base
for addressing a broader range of data needs.
ATSDR encourages the use of in vitro assessment methods and other
innovative tools for filling priority data needs. For example, the
Agency believes that physiologically based pharmacokinetic (PBPK)
modeling could serve as a valuable tool in predicting across route
similarities (or differences) in toxicological responses to hazardous
substances. Therefore, on a case-by-case basis, a priority data need
can be filled using existing data and modeling. In addition, ATSDR is a
member of NTP's InterAgency Coordinating Committee on the Validation of
Alternative Methods (ICCVAM) and supports development, validation, and
acceptance of alternative toxicological test methods that reduce,
refine, and replace the use of animals, as appropriate.
CERCLA section 104(i)(5)(D) 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 substance in question,''
as required in TSCA and the Federal Insecticide, Fungicide, and
Rodenticide Act of 1972 [7 U.S.C. 136 et seq.] (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 the regulatory mechanisms referenced (TSCA/FIFRA),
private-sector voluntarism, and the direct use of CERCLA funds.
The TASARC, composed of scientists from ATSDR, NIEHS/NTP, and EPA,
has been set up to:
(1) Advise ATSDR on the assignment of priorities for mechanisms to
address data needs,
(2) Coordinate knowledge of research activities to avoid
duplication of research in other programs and under other authorities,
(3) Advise ATSDR on issues of science related to substance-specific
data needs, and
(4) Maintain a scheduled forum that provides an overall review of
the ATSDR SSARP.
TASARC has met 12 times since the initiation of the SSARP. It has
guided referral of priority data needs to EPA and the associated
development of test rules through TSCA. In addition, it has endorsed
the proposals of several private-sector organizations to conduct
voluntary research. Furthermore, TASARC has become a forum for other
federal agencies to bring forth their research agendas. For example, it
has coordinated research efforts on hazardous pollutants with the
Office of Air and Radiation, EPA. TASARC has developed testing
guidelines for immunotoxicity; and has endorsed the use of decision-
support methodologies such as physiologically based pharmacokinetic
(PBPK) modeling and benchmark-dose modeling, where appropriate.
Additional priority data needs are being addressed through
collaborative research efforts with NTP, by ATSDR's Great Lakes Human
Health Effects Research Program, and other Agency programs.
Criteria for Evaluating Status of Priority Data Needs
To update the activities covered under the SSARP, criteria for
evaluating the status of the priority data needs were developed. Based
on these criteria and the review of the current literature, a priority
data need can be filled, or unchanged.
The criteria for evaluating the status of the priority data needs
are described below.
General Criteria
A priority data need is filled:
If it has been referred to one of the implementation
mechanisms and research has been initiated (Exception: priority data
needs referred to EPA [i.e., included in the EPA/ATSDR test rule] and/
or ATSDR Voluntary Research Program remain as priority data needs until
the studies have been completed, peer reviewed and accepted by ATSDR),
OR
If an updated ATSDR toxicological profile contains
relevant new studies, or if other relevant, peer-reviewed, and publicly
available new studies (not included in the toxicological profile) have
been identified since the finalization of the priority data needs
document; and based on such studies, it is generally agreed that a
priority data need has been filled.
Furthermore, in the event a priority data need is considered
filled, it does not necessarily mean that the study has been completed
and that ATSDR has accepted the data. It does, however, indicate that
the Agency no longer considers it a priority to initiate additional
studies at this time.
A priority data need remains unchanged:
If no mechanism or information has been identified to
address the priority data need, or
If the priority data need is included in the ATSDR/EPA
test rule under development and/or ATSDR Voluntary Research Program, or
it is associated with a pilot substance in EPA's Voluntary Children's
Chemical Evaluation Program.
Specific Criteria
Examples of specific criteria for two categories of priority data
needs are described below.
Epidemiologic studies--A priority data need is filled if
multiple new studies assessing key health end points are available in
ATSDR's updated toxicological profile and/or ongoing studies have been
identified, e.g., human health studies supported by ATSDR's Great Lakes
Human Health Effects Research Program or the Minority Health
Professions Foundation Research Program. In some cases, ATSDR indicates
that it will continue to evaluate new data as they become available to
determine whether additional studies are needed.
Exposure levels in humans (adults and/or children)--A
priority data need is filled if (a) there are current and adequate
biomonitoring data for exposed populations associated with health
effects (from published or ongoing studies), or (b) there are reference
range data (e.g., the Centers for Disease Control and Prevention's
Third
[[Page 73751]]
National Report on Human Exposure to Environmental Chemicals, with data
from a random sample of participants from the National Health and
Nutrition Examination Survey [NHANES] ) or generally agreed upon
background population levels. In the latter case, ATSDR acknowledges
that reference concentration data can support exposure and health
assessments at waste sites, but the Agency also continues to recognize
the importance of collecting additional data on uniquely exposed
populations at waste sites. It should be noted that for some of the
chemicals listed in the National Report, the measurements are reported
as below the limit of detection (LOD) for those chemicals. However, the
LODs for all the chemicals monitored are available in the Report, and
therefore, these data can be considered as estimates of background
exposure levels.
In updating the SSARP, the status of the priority data needs may
change as new information becomes available. Further, during the
literature review, new studies may be identified suggesting other
effects of concern, such as those related to endocrine disruptors and
children's health, which were not included in the original list of
priority data needs. In such cases, additional priority data needs may
be added to the research agenda. For example, in addressing issues
relating to children's health, ATSDR considers it a priority to obtain
data on exposure levels in children; therefore, when such information
is available, it is used to fill this additional priority data need
(e.g., cadmium, chlordane, chlorinated dibenzo-p-dioxins, DDT, lead,
and pentachlorophenol, see Table 1).
In contrast, the Agency may consider a previously identified
priority data need to no longer be a priority to fill at this time and
thus be deleted from the list of priority data needs. However, it
remains a data need for the Agency. For example, as a result of
reevaluation of the database for di-n-butyl phthalate, two of its
previously identified priority data needs, i.e., immunotoxicity and
neurotoxicty studies via oral exposure are no longer considered to be
priority data needs. This is due to the fact that the immune system
does not appear to be a target for di-n-butyl phthalate toxicity and
that additional neurotoxicty studies do not seem necessary because of
the lack of effects seen in long-term neurotoxicty studies. In
addition, under the Agency's Voluntary Research Program, the
Halogenated Solvents Industry Alliance, Inc. (HSIA) proposed to fill a
trichloroethylene priority data need (dose-response data for
intermediate-duration, oral exposure) by conducting PBPK modeling to
obtain the data for oral exposure using existing inhalation data.
However, ATSDR is concerned that, based on the existing data for this
exposure duration, it is not clear if the most sensitive end point for
oral exposure is the same as that for inhalation exposure. Therefore,
the Agency believes it is prudent not to consider it a priority to
conduct a PBPK study to obtain the oral data at this time pending
evaluation of additional information. This is reflected in Table 1 from
which this priority data need has been deleted.
Update of Activities in the SSARP
An update of the activities associated with the mechanisms for
implementing the ATSDR Substance-Specific Applied Research Program
(SSARP) is discussed below.
A. TSCA/FIFRA
In developing and implementing the SSARP, ATSDR, NIEHS/NTP, and EPA
have identified a subset of priority data needs for substances of
mutual interest to the federal programs. These priority data needs are
being addressed through a program of toxicological testing under TSCA
according to established procedures and guidelines. On several
occasions when ATSDR identified priority data needs for oral exposure,
other agencies needed inhalation data. In response, ATSDR considers
proposals to conduct inhalation studies in conjunction with
physiologically based pharmacokinetic (PBPK) studies in lieu of oral
studies. ATSDR expects that inhalation data derived from these studies
can be used with PBPK modeling to address its oral toxicity priority
data needs. Currently, an EPA/ATSDR test rule, under development,
includes eight ATSDR substances, i.e., benzene, chloroethane, cyanide
(hydrogen cyanide and sodium cyanide), methylene chloride,
tetrachloroethylene, toluene and trichloroethylene, and addresses 13
ATSDR priority data needs (Table 2). The test rule is presently
undergoing ATSDR and EPA final review and is anticipated to be
available for public comment in Spring 2006.
At least seven metals included in the ATSDR's SSARP (arsenic,
beryllium, chromium, manganese, mercury, nickel, and selenium,
associated with 21 priority data needs) (Table 2) have been forwarded
to EPA through TASARC for toxicity testing. The EPA is currently
developing a risk assessment framework for metals. Once the framework
has been adopted, the EPA will solicit testing proposals for these
metals and pursue appropriate testing mechanisms at a later date.
B. Private-Sector Voluntarism
As part of the Substance-Specific Applied Research Program (SSARP),
ATSDR announced a set of proposed procedures for conducting voluntary
research in the Federal Register (57 FR 4758) on February 7, 1992.
Revisions based on public comments were published on November 16, 1992
(57 FR 54160). Private-sector organizations are encouraged to volunteer
to conduct research to fill specific priority data needs at no expense
to ATSDR. All study protocols and final reports are subjected to
ATSDR's external peer review, and ATSDR accepts the study results based
on the peer reviewers' recommendation and the industry groups'
satisfactory response to the reviewers' comments.
To date, ATSDR has established memoranda of understanding with four
industry groups. Through the voluntary research efforts of these
organizations, at least 15 research needs (12 priority data needs and 3
data needs) for methylene chloride, tetrachloroethylene
(perchloroethylene), trichloroethylene, polychlorinated biphenyl
compounds [PCBs], and vinyl chloride have been or are being filled
(Table 2).
Industry groups which conducted studies under the Voluntary
Research Program include: The American Chemistry Council (ACC)
[formerly the Chemical Manufacturers Association (CMA)] ATSDR accepted
the ACC studies ``Vinyl chloride: Combined inhalation two-generation
reproduction and developmental toxicity study in CD rats.''
General Electric Company (GE)
GE conducted studies on polychlorinated biphenyls including ``An
assessment of the chronic toxicity and oncogenicity of Aroclors 1016,
1242, 1254, and 1260 administered in diet to rats,'' ``PCB congener
analyses,'' and ``Metabolite detection as a tool for determining
naturally occurring aerobic PCB biodegradation.'' Although these
studies do not specifically address ATSDR's priority data needs for
PCBs, they do address other Agency research needs for these substances.
Halogenated Solvents Industry Alliance, Inc. (HSIA)
To date, ATSDR has entered into five MOUs with HSIA to conduct
studies to fill priority data needs for methylene chloride,
tetrachloroethylene and trichloroethylene. In addition, in 2002, HSIA
signed a letter of agreement with ATSDR stating that HSIA volunteers to
[[Page 73752]]
conduct studies to fill ATSDR's remaining priority data needs for
tetrachloroethylene (perchloroethylene) and trichloroethylene. These
studies are being done in conjunction with the EPA/ATSDR test rule and
EPA's Voluntary Children's Chemical Evaluation Program. In some cases,
HSIA first conducted a study via inhalation which was followed by route
extrapolation via PBPK modeling to obtain data for oral exposure. This
is because, for specific chemicals, EPA requires inhalation data while
ATSDR has determined that ingestion of contaminated environmental media
is the primary exposure route at hazardous waste sites.
HSIA studies accepted by ATSDR include: Addressing priority data
needs for methylene chloride with physiologically based pharmacokinetic
modeling'' which evaluates acute- and subchronic-duration toxicity and
developmental toxicity via oral exposure.
``Methylene chloride: 28 day inhalation toxicity study in the rat
to assess potential immunotoxicity.''
``Immunotoxic potential of orally administered dichloromethane from
immunotoxicty studies conducted by the inhalation route.'' (PBPK
modeling)
``Trichloroethylene: Inhalation developmental toxicity study in CD
rats.'' HSIA will conduct PBPK modeling to obtain data for oral
exposure based on the inhalation data.
``Trichloroethylene (TCE): Immunotoxicity potential in CD rats
following a 4-week vapor inhalation exposure.'' The final report of the
study is undergoing ATSDR's external peer review. Pending ATSDR's
acceptance of the inhalation study, HSIA will conduct PBPK modeling to
obtain data for oral exposure based on the inhalation data.
``Perchloroethylene: Study of effects on embryo-fetal development
in CD rats by inhalation administration.'' HSIA will conduct PBPK
modeling to obtain data for oral exposure based on the inhalation data.
Electric Power Research Institute, Inc. (EPRI)
In addition to the substance-specific MOUs described above, ATSDR
also signed an MOU with EPRI to conduct a study ``Validation of test
methods for assessing neurodevelopment in children.'' In this
particular case, ATSDR and three other federal agencies (the Food and
Drug Administration, EPA, and NIEHS) were also funding partners.
C. CERCLA-Funded Research (Minority Health Professions Foundation
Research Program)
During FY 1992, ATSDR announced a $4 million cooperative agreement
program with the Minority Health Professions Foundation (MHPF) to
support substance-specific investigations. A not-for-profit Internal
Revenue Code 501(c)(3) organization, the MHPF comprises 11 minority
health professions schools at historically black colleges and
universities. The MHPF mission is to research health problems that
disproportionately affect poor and minority citizens. The purpose of
the cooperative agreement was to address substance-specific data needs
for priority hazardous substances identified by ATSDR. In addition, the
agreement strengthened the environmental health research opportunities
for scientists and students at MHPF member institutions and enhanced
existing disciplinary capacities to conduct research in toxicology and
environmental health. The MHPF published a report, ``Environmental
Health and Toxicology Research Program: Meeting Environmental Health
Challenges Through Research, Education, and Service,'' that describes
the research findings and other successes from the first 5 years of the
program.
In the first five year project period that concluded during FY
1997, nine priority data needs for 21 priority hazardous substances and
22 other research needs for these and other substances were addressed.
Research initiated in the second 5-year project period included studies
to address 10 additional priority data needs for chlordane, di-n-butyl
phthalate, lead, manganese, the polycylic aromatic hydrocarbons (PAHs),
zinc, and eight other research needs. To date, 14 priority data needs
have been filled through this cooperative agreement (Table 1).
During 2003, ATSDR announced a new five year cooperative agreement
program with the MHPF. The purpose of the program is to apply findings
from the previous ten year environmental health and Toxicology Research
Program and to improve public health and environmental medicine in low-
income and minority communities. The new program builds on earlier
efforts and expands the Program's public environmental health impact on
affected communities. Activities across the following four research and
environmental public health focus areas were funded to initiate this
new program: substance-specific toxicology research, environmental
exposure assessment, community-based environmental health education,
and environmental health education for primary-care providers. No
additional priority data needs are being addressed under this new
program.
To date, Program research findings and other activities have
resulted in the publication of more than 50 manuscripts in peer-
reviewed journals. The institutions which have received awards and
their respective studies are listed in Table 2.
D. National Toxicology Program (NTP)
Section 104(i)(5) of CERCLA directs the administrator of ATSDR (in
consultation with the administrator of EPA and agencies and programs of
the Public Health Service) to assess whether adequate information on
the health effects of priority hazardous substances found at NPL sites
is available. Where adequate information is not available, ATSDR, in
cooperation with the National Toxicology Program (NTP), is required to
assure the initiation of a program of research designed to determine
these health effects (and techniques for developing methods to
determine such health effects).
ATSDR continues to collaborate with NTP to address priority data
needs of mutual interest. Chemicals for which NTP has conducted studies
(or is in the process of conducting studies) to fill ATSDR's priority
data needs include carbon tetrachloride, 1,1-dichloroethene, di-n-butyl
phthalate, disulfoton, and heptachlor (Table 2).
E. Great Lakes Human Health Effects Research Program
Some of the priority data needs identified in the SSARP have been
independently identified as research needs through the ATSDR Great
Lakes Human Health Effects Research Program, a separate research
program.
In support of the Great Lakes Critical Programs Act of 1990, ATSDR
announced in Fiscal Year 1992 the availability of $2 million for a
grant program to conduct research on the potential for short- and long-
term adverse health effects from consumption of contaminated fish from
the Great Lakes basin. Research undertaken through this program is
intended to build on and amplify the results of past and ongoing fish
consumption research in the Great Lakes basin. The ATSDR-supported
research projects focus on known high-risk populations to define
further the human health consequences of exposure to persistent toxic
substances (PTSs) identified in the Great Lakes basin. These at-risk
populations include sport anglers; African
[[Page 73753]]
Americans, Asians and other non-English speaking populations; pregnant
women; fetuses, nursing infants, and children of mothers who consume
contaminated Great Lakes sport fish; the elderly, and the urban poor.
To date, the research activities of the ATSDR Great Lakes Human Health
Effects Research Program have resulted in 70 publications in peer-
reviewed journals.
Currently, 14 priority data needs for 24 priority hazardous
substances (including 15 PAHs) identified in the SSARP are being
addressed through this program. The institutions which have received
awards and their respective studies are listed in Table 2.
F. Other ATSDR Programs
In its role as a public health agency addressing environmental
health, ATSDR may collect human data to validate substance-specific
exposure and toxicity findings. The need for additional information on
levels of contaminants in humans has been identified, and remains as a
priority data need for 59 of the 60 priority substances (Table 1). In
some cases, ATSDR anticipates obtaining this information through
exposure and health effects studies, and through establishing and using
substance-specific subregistries of people within the Agency's National
Exposure Registry who have potentially been exposed to these
substances. Regarding the priority data need for exposure
subregistries, the list of the 60 priority hazardous substances in the
SSARP was forwarded to ATSDR's Division of Health Studies for
consideration as potential candidates for subregistries of exposed
persons, based on criteria described in its 1994 document, ``National
Exposure Registry: Policies and Procedures Manual (Revised),'' Agency
for Toxic Substances and Disease Registry, Public Health Service, U.S.
Department of Health and Human Services, Atlanta, Georgia, NTIS
Publication No. PB95-154571. Currently, ATSDR has established exposure
subregistries for benzene, dioxin, 1,1,1-trichloroethane (not included
in the SSARP), trichloroethylene, and tremolite asbestos.
G. Conclusion
The results of the research conducted via the SSARP are expected to
provide information necessary to improve the database used to conduct
comprehensive public health assessments of populations living near
hazardous waste sites. The information will enable the Agency to
establish linkages between levels of contaminants in the environment
and levels in human tissue and organs associated with adverse health
effects, ultimately helping to determine methods for interdicting
exposure and mitigating toxicity. This program will also provide data
that can be generalized to other substances or areas of science,
including risk assessment of chemicals, thus creating a scientific
information base for addressing a broader range of data needs. The
Agency plans to provide an update on the status of this research
program approximately every three years or sooner, as needed.
Dated: November 17, 2005.
Kenneth Rose,
Acting Director, Office of Policy, Planning, and Evaluation, National
Center for Environmental Health/Agency for Toxic Substances and Disease
Registry.
Table 1.--ATSDR's Substance-Specific Priority Data Needs for 60 Priority Hazardous Substances
----------------------------------------------------------------------------------------------------------------
Status change
Substances PDN ID \1\ PDN description Program \2\ \3\ Comments \4\
----------------------------------------------------------------------------------------------------------------
Aldrin/Dieldrin............... 1A.......... Dose-response .............. Filled........ An MRL was
data in animals derived in the
for 2000 updated
intermediate- ATSDR
duration oral toxicological
exposure. profile.
1B.......... Bioavailability
from soil.
1C.......... Exposure levels .............. .............. This priority
in humans data need,
living near previously
hazardous waste addressed in a
sites and other study in the
populations, Great Lakes
such as exposed Research
workers. Program, is no
longer
investigated in
that study.
1D.......... Potential ATSDR.........
candidate for
subregistry of
exposed persons.
Arsenic....................... 2A.......... Comparative EPA...........
toxicokinetic
studies to
determine if an
appropriate
animal species
can be
identified.
2B.......... Half-lives in EPA...........
surface water,
groundwater.
2C.......... Bioavailability EPA...........
from soil.
2D.......... Exposure levels G. Lakes...... Filled........ In addition to
in humans the data from
living near the Great Lakes
hazardous waste Research
sites and other Program,
populations, background
such as exposed level data are
workers. available in
ATSDR's 1993
toxicological
profile, and at
least seven
ATSDR studies
that evaluated
urine arsenic
levels and
potential
adverse health
effects are
available.
Also,
additional
studies are
available in
ATSDR's 2000
updated
toxicological
profile.
[[Page 73754]]
Asbestos...................... 3A.......... Epidemiologic
studies of
individuals
occupationally
exposed to
asbestos levels
lower than
those
experienced
before the
institution of
current
occupational
standards
governing the
use of
asbestos, but
higher than
current levels
in the general
population.
These studies
should be
performed in
conjunction
with the
immunotoxicity
studies.
3B.......... Immunotoxicity
studies of
individuals
occupationally
exposed to
asbestos.
3C.......... Development of
human and rat
lung retention
models to aid
in
extrapolating
between rat and
human data.
3D.......... Improved
analytical
methods for
screening
samples and
determining the
chemical
structure of
asbestos
fibers. Also,
techniques are
needed to
normalize
studies in
which different
analytical
methods were
employed.
3E.......... Exposure levels,
fiber size
distribution,
and asbestos
fiber type in
areas with
natural
geologic
deposits of
friable
asbestos and at
hazardous waste
sites. Also,
techniques for
estimating air
levels of
asbestos from
soil
concentrations
and activity
scenarios.
3F.......... Exposure levels
in humans
living near
hazardous waste
sites and in
other
populations,
such as humans
living in areas
with naturally
high levels of
friable
asbestos.
3G.......... Potential ATSDR......... Filled........ ATSDR
candidate for established
subregistry of registry to
exposed persons. follow the
health of
people who were
exposed to
asbestos in
Libby, Montana.
The name of the
registry is the
Tremolite
Asbestos
Registry (TAR).
Benzene....................... 4A.......... Dose-response EPA........... .............. Reproductive
data in animals toxicity study
for acute- and is the only
intermediate- component of
duration oral this PDN that
exposure. The is included in
subchronic the EPA/ATSDR
study should test rule.
include an
extended
reproductive
organ
histopathology.
4B.......... Prenatal EPA........... .............. Previously
developmental planned study
toxicity study in the MHPF
via oral Research
exposure. Program to
address this
priority data
need was
canceled.
4C.......... Neurotoxicology EPA...........
battery of
tests via oral
exposure.
4D.......... Epidemiologic .............. Filled........ Based on an
studies on the evaluation of
health effects the data in
of benzene ATSDR's 1997
(Special updated
emphasis end toxicological
points include profile. ATSDR
immunotoxicity). will continue
to evaluate new
data as they
become
available to
determine if
additional
studies are
needed.
[[Page 73755]]
4E.......... Exposure levels .............. Filled........ Reference range
in humans concentrations
living near are available
hazardous waste (Ashley et al.
sites and other 1992, 1994;
populations, Needham et al.
such as exposed 1995), and at
workers. least one ATSDR
study that
evaluated blood
benzene levels
and potential
adverse health
effects is
available.
ATSDR
acknowledges
that reference
concentration
data can
support
exposure and
health
assessments at
waste sites,
but the Agency
also continues
to recognize
the importance
of collecting
additional data
on uniquely
exposed
populations at
waste sites.
Benzidine..................... 5A.......... Dose-response
data for acute-
and
intermediate-
duration
exposure via
the oral route
(the study of
intermediate-
duration
exposure should
include
evaluation of
reproductive
and endocrine
organ
histopathology,
lymphoid
tissues
histopathology
as well as
examination of
relevant blood
components, and
nervous system
histopathology).
5B.......... Exposure levels
in humans
living near
hazardous waste
sites.
5C.......... Exposure levels
in children.
5D.......... Potential ATSDR.........
candidate for
subregistry of
exposed persons.
Beryllium..................... 6A.......... Dose-response EPA...........
data in animals
for acute- and
intermediate-
duration
inhalation
exposures. The
subchronic
study should
include
extended
reproductive
organ
histopathology.
6B.......... Prenatal EPA...........
developmental
toxicity study
via inhalation
exposure.
6C.......... Environmental EPA...........
fate in air;
factors
affecting
bioavailability
in air.
6D.......... Analytical .............. Filled........ Based on an
methods to evaluation of
determine the data in
environmental ATSDR's 2000
speciation. updated
toxicological
profile.
6E.......... Immunotoxicology EPA...........
battery of
tests following
oral exposure.
6F.......... Exposure levels .............. Filled........ Reference range
in humans concentrations
(adults) living in urine are
near hazardous available
waste sites and (Paschal et al.
other 1998, CDC
populations, 2005). ATSDR
such as exposed acknowledges
workers. that reference
concentration
data can
support
exposure and
health
assessments at
waste sites,
but the Agency
also continues
to recognize
the importance
of collecting
additional data
on uniquely
exposed
populations at
waste sites.
6G.......... Exposure levels .............. Filled........ Reference range
in children. concentrations
in urine are
available (CDC
2005).
6H.......... Potential ATSDR.........
candidate for
subregistry of
exposed persons.
Cadmium....................... 7A.......... Analytical .............. Filled........ Based on an
methods for evaluation of
biological the data in
tissues and ATSDR's 1999
fluids and updated
environmental toxicological
media. profile.
[[Page 73756]]
7B.......... Exposure levels G. Lakes...... Filled........ In addition to
in humans the data from
(adults) living the Great Lakes
near hazardous Research
waste sites and Program,
other reference range
populations, concentrations
such as exposed in blood and
workers. urine are
available (CDC
2005), and at
least nine
ATSDR studies
that evaluated
blood and urine
cadmium levels
and potential
adverse health
effects are
available.
7C.......... Exposure levels .............. Filled........ Reference range
in children. concentrations
in blood and
urine are
available (CDC
2005).
Carbon tetrachloride.......... 8A.......... Dose-response
data in animals
for chronic
oral exposure.
The study
should include
extended
reproductive
organ and
nervous tissue
histopathology.
8B.......... Immunotoxicology NTP........... Filled........ NTP dose-finding
battery of study and one
tests via oral study in
exposure. ATSDR's 1994
updated
toxicological
profile
addressed the
priority data
need.
8C.......... Half-life in .............. Filled........ One study in
soil. ATSDR's 1994
updated
toxicological
profile
provided
information on
half-life in
soil.
8D.......... Exposure levels .............. Filled........ Reference range
in humans concentrations
living near in blood are
hazardous waste available
sites and other (Ashley et al.
populations, 1992, 1994;
such as exposed Needham et al.
workers. 1995). ATSDR
acknowledges
that reference
concentration
data can
support
exposure and
health
assessments at
waste sites,
but the Agency
also continues
to recognize
the importance
of collecting
additional data
on uniquely
exposed
populations at
waste sites.
8E.......... Potential ATSDR.........
candidate for
subregistry of
exposed persons.
Chlordane..................... 9A.......... Oral MHPF.......... Filled........ Availability of
multigeneration studies in the
al studies to MHPF Research
evaluate Program.
reproductive
toxicity.
9B.......... Bioavailability
studies
following
ingestion of
contaminated
media.
9C.......... Exposure levels .............. Filled........ Reference range
in humans concentrations
(adults) living in serum are
near hazardous available (CDC
waste sites and 2005). ATSDR
other acknowledges
populations that reference
potentially concentration
exposed to data can
chlordane. support
exposure and
health
assessments at
waste sites,
but the Agency
also continues
to recognize
the importance
of collecting
additional data
on uniquely
exposed
populations at
waste sites.
9D.......... Exposure levels .............. Filled........ Reference range
in children. concentrations
in serum are
available (CDC
2005).
9E.......... Potential ATSDR.........
candidate for
subregistry of
exposed persons.
Chlorinated dibenzo-p-dioxins 10A......... Studies via oral
(CDDs). exposure
designed to
assess
childhood
susceptibility.
[[Page 73757]]
10B......... Comparative
toxicokinetic
studies
examining the
relative
absorption of
CDDs across
exposure routes
and the
relative
contribution of
each exposure
route to total
body burdens.
10C......... Exposure levels .............. Filled........ Reference range
in humans concentrations
(adults) living in serum are
near hazardous available (CDC
waste sites. 2005). ATSDR
acknowledges
that reference
concentration
data can
support
exposure and
health
assessments at
waste sites,
but the Agency
also continues
to recognize
the importance
of collecting
additional data
on uniquely
exposed
populations at
waste sites.
10D......... Exposure levels .............. Filled........ Reference range
in children. concentrations
in serum are
available (CDC
2005).
Chloroethane.................. 11A......... Dose-response EPA...........
data in animals
for acute- and
intermediate-
duration oral
exposures. The
subchronic
study should
include an
evaluation of
immune and
nervous system
tissues, and
extended
reproductive
organ
histopathology.
11B......... Dose-response EPA...........
data in animals
for chronic
inhalation
exposures. The
study should
include an
evaluation of
nervous system
tissues.
11C......... Potential ATSDR.........
candidate for
subregistry of
exposed persons.
Chloroform.................... 12A......... Dose-response .............. Filled........ An MRL was
data in animals derived in
for ATSDR's 1997
intermediate- updated
duration oral toxicological
exposure. profile.
12B......... Epidemiologic .............. Filled........ Based on an
studies on the evaluation of
health effects the data in
of chloroform ATSDR's 1997
(Special updated
emphasis end toxicological
points include profile. ATSDR
cancer, will continue
neurotoxicity, to evaluate new
reproductive data as they
and become
developmental available to
toxicity, determined if
hepatotoxicity, additional
and renal studies are
toxicity). needed.
12C......... Exposure levels .............. Filled........ Reference range
in humans concentrations
living near in blood are
hazardous waste available
sites and other (Ashley et al.
populations, 1992, 1994; and
such as exposed Needham et al.
workers. 1995). ATSDR
acknowledges
that reference
concentration
data can
support
exposure and
health
assessments at
waste sites,
but the Agency
also continues
to recognize
the importance
of collecting
additional data
on uniquely
exposed
populations at
waste sites.
12D......... Potential ATSDR.........
candidate for
subregistry of
exposed persons.
Chromium...................... 13A......... Dose-response EPA...........
data in animals
for acute-
duration
exposure to
chromium (VI)
and (III) via
oral exposure
and for
intermediate-
duration
exposure to
chromium (VI)
via oral
exposure.
13B......... Multigeneration EPA...........
reproductive
toxicity study
via oral
exposure to
chromium (III)
and (VI).
[[Page 73758]]
13C......... Immunotoxicology EPA...........
battery of
tests following
oral exposure
to chromium
(III) and (VI).
13D......... Prenatal EPA...........
developmental
toxicity study
via oral
exposure to
chromium (III)
and (VI).
13E......... Exposure levels G. Lakes...... Filled........ In addition to
in humans the data from
living near the Great Lakes
hazardous waste Research
sites and other Program,
populations, reference range
such as exposed concentrations
workers. in urine are
available
(Paschal et al.
1998). Also, at
least two ATSDR
studies that
evaluated urine
chromium levels
and potential
adverse health
effects are
available.
Cyanide....................... 14A......... Dose-response EPA...........
data in animals
for acute- and
intermediate-
duration
exposures via
inhalation. The
subchronic
study should
include
extended
reproductive
organ
histopathology
and evaluation
of
neurobehavioral
and
neuropathologic
al end points.
14B......... Prenatal EPA...........
developmental
toxicity study
via oral
exposure.
14C......... Evaluation of .............. Filled........ A study
the addressing the
environmental priority data
fate of cyanide need was
in soil. submitted by
industry to EPA
in response to
EPA's
solicitation
for proposals
for test rule
making.
Scientists from
EPA and ATSDR
reviewed the
study and
considered that
this research
need is no
longer a
priority.
14D......... Exposure levels
in humans
living near
hazardous waste
sites and other
populations,
such as exposed
workers.
14E......... Potential ATSDR.........
candidate for
subregistry of
exposed persons.
1,2-dibromo-3-chloropropane... 15A......... Dose-response
data in animals
for acute-
duration
exposure via
the oral route
(including
reproductive
organ
histopathology).
15B......... Dose-response
data in animals
for chronic-
duration
exposure via
the oral route
(including
reproductive
organ
histopathology).
15C......... Prenatal
developmental
toxicity study
via oral
exposure.
15D......... Immunotoxicology .............. .............. Previously
testing battery planned study
via oral in the MHPF
exposure. Research
Program to
address this
priority data
need was
canceled.
15E......... Neurotoxicology .............. .............. Previously
testing battery planned study
via oral in the MHPF
exposure. Research
Program to
address this
priority data
need was
canceled.
15F......... Exposure levels
in humans
living near
hazardous waste
sites and other
exposed
populations,
such as exposed
workers.
15G......... Potential ATSDR.........
candidate for
subregistry of
exposed persons.
[[Page 73759]]
1,2-Dibromoethane............. 16A......... Dose-response
data in animals
for acute- and
intermediate-
duration
exposure by the
oral route (the
study of
intermediate-
duration
exposure should
include
evaluation of
neuropathology
and observation
for overt signs
of
neurotoxicity).
16B......... Multigeneration
reproductive
toxicity
studies via
oral exposure.
16C......... Developmental
toxicity
studies via
oral exposure.
16D......... Immunotoxicity
battery studies
via oral
exposure.
16E......... Exposure levels
in humans
living near
hazardous waste
sites and in
other
populations,
such as workers
exposed to 1, 2-
dibromoethane.
16F......... Exposure levels
in children.
16G......... Potential ATSDR.........
candidate for
subregistry of
exposed persons.
1,2-Dichloroethane............ 17A......... Dose-response
data in animals
for acute-
duration (14-
day) exposure
by the
inhalation
route,
including a
comparison of
young and adult
animals.
17B......... Dose-response
data in animals
for acute-
duration (14-
day) exposure
by the oral
route,
including a
comparison of
young and adult
animals.
17C......... Dose-response
data in animals
for
intermediate-
duration
exposure by the
inhalation
route (the
study should be
performed in
conjunction
with the
neurotoxicology
battery of
tests).
17D......... Neurotoxicology
battery of
tests following
inhalation
exposure.
17E......... Neurotoxicology
battery of
tests following
oral exposure.
17F......... Dose-response
data in animals
for chronic-
duration
exposure by the
oral route.
17G......... Prenatal
developmental
toxicity data
for inhalation
exposure
(assessment of
developmental
cardiotoxicity
and
neurotoxicity).
17H......... Prenatal
developmental
toxicity data
for oral
exposure
(assessment of
developmental
cardiotoxicity
and
neurotoxicity).
17I......... Additional
analyses and
studies for
comparative
toxicokinetics
across species,
ages, routes,
and durations.
17J......... Children's
susceptibility.
17K......... Exposure levels
in humans
living near
hazardous waste
sites.
17L......... Exposure levels
in children.
17M......... Potential ATSDR.........
candidate for
subregistry of
exposed persons.
1,1-Dichloroethene............ 18A......... Dose-response NTP........... Filled........ Availability of
data in animals ongoing NTP
for acute- study.
duration
exposure by the
inhalation
route.
[[Page 73760]]
18B......... Dose-response NTP........... Filled........ Availability of
data in animals ongoing NTP
for chronic- study.
duration
exposure by the
inhalation
route.
18C......... Dose-response
data in animals
for acute- and
intermediate-
duration
exposure by the
oral route.
18D......... Carcinogenicity
studies in two
species
following
inhalation
exposure.
18E......... Reproductive
toxicity
studies
assessing male
and female end
points
following
inhalation
exposure.
18F......... Prenatal
developmental
toxicity
studies
following oral
exposure.
18G......... Immunotoxicology
battery of
tests following
oral exposure.
18H......... Battery of
neurobehavioral
tests following
inhalation
exposure.
18I......... Children's
susceptibility.
18J......... Exposure levels
in humans
living near
hazardous waste
sites.
18K......... Exposure levels
in children.
18L......... Potential ATSDR.........
candidate for
subregistry of
exposed persons.
DDT........................... 19A......... Dose-response
data in animals
for chronic-
duration oral
exposure.
19B......... Comparative
toxicokinetic
study (across
routes/species).
19C......... Bioavailability
and
bioaccumulation
from soil.
19D......... Epidemiologic G. Lakes...... Filled........ In addition to
studies on the the data from
health effects the Great Lakes
of DDT, DDD, Research
and DDE Program,
(Special multiple
emphasis end studies in
points include ATSDR's 2000
immunotoxicity, updated
and toxicological
reproductive profile are
and available.
developmental
toxicity).
19E......... Exposure levels G. Lakes...... Filled........ In addition to
in humans the data from
(adults) living the Great Lakes
near hazardous Research
waste sites and Program,
other reference range
populations, concentrations
such as exposed in serum are
workers. available (CDC
2005). ATSDR
acknowledges
that reference
concentration
data can
support
exposure and
health
assessments at
waste sites,
but the Agency
also continues
to recognize
the importance
of collecting
additional data
on uniquely
exposed
populations at
waste sites.
19F......... Exposure levels .............. Filled........ Reference range
in children. concentrations
in serum are
available (CDC
2005).
19G......... Potential ATSDR.........
candidate for
subregistry of
exposed persons.
Di (2-ethylhexyl) phthalate... 20A......... Epidemiologic
studies on the
health effects
of DEHP
(Special
emphasis end
points include
cancer).
[[Page 73761]]
20B......... Dose-response .............. .............. This research
data in animals need remains as
for acute- and a priority data
intermediate- need because
duration oral the previously
exposures. The developed MRL
subchronic for acute-
study should duration (1993
include an toxicological
extended profile) was
histopathologic withdrawn.
evaluation of However, a new
the immunologic MRL for
and neurologic intermediate-
systems. duration was
derived in
ATSDR's 2002
updated
Toxicological
Profile.
Therefore, this
priority data
need is
considered
partially
filled because
additional
adequate acute-
duration data
for deriving an
MRL are still
lacking.
20C......... Multigeneration .............. .............. This research
reproductive need is
toxicity study reassigned as a
via oral priority data
exposure. need based on
an evaluation
of the data in
ATSDR's 2002
updated
toxicological
profile. Also,
the NTP Center
for the
Evaluation of
Risks to Human
Reproduction
Expert Panel
Report (October
2000) has
identified
critical data
needs for
reproductive
toxicity.
20D......... Comparative .............. Filled........ The existing
toxicokinetic database
studies provides
(Studies adequate
designed to information to
examine how fill this
primates priority data
metabolize and need based on
distribute DEHP ATSDR's
as compared reevaluation of
with rodents the published
via oral data.
exposure).
20E......... Exposure levels
in humans
living near
hazardous waste
sites and other
populations,
such as exposed
workers.
20F......... Potential ATSDR.........
candidate for
subregistry of
exposed persons.
Di-n-butyl phthalate.......... 21A......... Dose-response NTP........... Filled........ Availability of
data in animals an NTP study.
for acute-
duration
exposure via
the oral route.
21B......... Dose-response
data in animals
for chronic-
duration
exposure via
the oral route.
21C......... Carcinogenicity
studies via
oral exposure.
21D......... In vivo MHPF.......... Filled........ Availability of
genotoxicity a study in the
studies. MHPF Research
Program.
21E......... Exposure levels
in humans
living near
hazardous waste
sites and other
populations,
such as exposed
workers.
21F......... Environmental
fate of di-n-
butyl phthalate
in
environmental
media.
21G......... Bioavailability
in contaminated
environmental
media near
hazardous waste
sites.
21H......... Potential ATSDR.........
candidate for
subregistry of
exposed persons.
Disulfoton.................... 22A......... Immunotoxicology NTP........... Filled........ Availability of
testing battery ongoing NTP
following oral study.
exposure.
22B......... Exposure levels
of disulfoton
in tissues/
fluids for
populations
living near
hazardous waste
sites and other
populations,
such as exposed
workers.
22C......... Disulfoton ATSDR.........
should be
considered as a
potential
candidate for a
subregistry of
exposed persons.
[[Page 73762]]
Endosulfan ([alpha], [beta], 23A......... Acute-duration
and sulfate). oral exposure
studies.
23B......... Data on
sensitive
neurologic end
point following
oral exposure.
23C......... Exposure levels
in humans
living near
hazardous waste
sites and other
populations,
such as exposed
workers.
23D......... Data on the
bioavailability
of endosulfan
from soil.
23E......... Potential ATSDR.........
candidate for
subregistry of
exposed persons.
Endrin/endrin aldehyde........ 24A......... Dose-response
animal data for
acute oral
exposure to
endrin.
24B......... Multigeneration
reproductive
toxicity
studies via
oral exposure
to endrin.
24C......... Accurately
describe the
toxicokinetics
of endrin and
its degradation
products and
identify the
animal species
to be used as
the most
appropriate
model for human
exposure.
24D......... Exposure levels
for endrin and
its degradation
products in
humans living
near hazardous
waste sites.
24E......... Accurately
describe the
environmental
fate of endrin,
including
environmental
breakdown
products and
rates, media
half-lives, and
chemical and
physical
properties of
the breakdown
products that
help predict
mobility and
volatility.
24F......... Potential ATSDR.........
candidate for
subregistry of
exposed persons.
Ethylbenzene.................. 25A......... Dose-response
data for acute-
duration
exposure by the
inhalation
route.
25B......... Dose-response
data for
chronic-
duration
exposure by the
inhalation
route.
25C......... Dose-response
data for acute-
and
intermediate-
duration
exposure by the
oral route; the
study of
intermediate-
duration
exposure should
include an
evaluation of
clinical signs
of
neurotoxicity
and
histopathology
of reproductive
organs,
endocrine
glands, and
nervous system.
25D......... Multigeneration
toxicity study
examining
reproductive
end points and
indicators of
endocrine
disruption
following
inhalation
exposure.
25E......... Prenatal
developmental
study with
continued
assessment of
offspring
during
postnatal
development
following oral
exposure.
25F......... Studies for
comparative
toxicokinetics.
25G......... Exposure levels
in humans
living near
hazardous waste
sites.
25H......... Exposure levels
in children.
[[Page 73763]]
25I......... Potential ATSDR.........
candidate for
subregistry of
exposed persons.
Heptachlor/heptachlor epoxide. 26A......... Dose-response
animal data for
acute- and
intermediate-
duration oral
exposures,
including
immunopathology.
26B......... Multigeneration NTP........... Filled........ Availability of
reproductive publication
toxicity ``The effects
studies via the of perinatal/
oral route of juvenile
exposure. heptachlor
exposure on
adult immune
and
reproductive
system function
in rats'' by
Smialowicz et
al. (2001),
Toxicological
Sciences 61:164-
175.
26C......... Prenatal .............. Filled........ Based on ATSDR's
developmental review of the
toxicity literature,
studies via the i.e.,
oral route of Smialowicz et
exposure. al. (2001),
Toxicological
Sciences 61:164-
175 and Moser
et al. (2001)
Toxicological
Sciences 60
(2):315-326.
26D......... Exposure levels .............. Filled........ Reference range
in humans concentrations
(adults) living in serum are
near hazardous available (CDC
waste sites and 2005). ATSDR
other acknowledges
populations, that reference
such as exposed concentration
workers. data can
support
exposure and
health
assessments at
waste sites,
but the Agency
also continues
to recognize
the importance
of collecting
additional data
on uniquely
exposed
populations at
waste sites.
26E......... Exposure levels .............. Filled........ Reference range
in children. concentrations
in serum are
available (CDC
2005).
26F......... Bioavailability
from
contaminated
air, water, and
soil and
bioaccumulation
potential.
26G......... Potential ATSDR.........
candidate for
subregistry of
exposed persons.
Hexachlorobutadiene........... 27A......... Dose-response
data in animals
for acute-
duration
exposure via
the oral route.
27B......... Exposure levels
in humans
living near
hazardous waste
sites and other
populations,
such as exposed
workers.
27C......... Environmental
fate studies
that determine
the extent to
which hexa
chloro but
adiene
volatilizes
from soil, and
studies that
determine the
reactions and
rates which
drive
degradation in
soil.
27D......... Bioavailability
studies in soil
and plants.
27E......... Potential ATSDR.........
candidate for
subregistry of
exposed persons.
Hexachlorocyclohexane 28A......... Dose-response .............. Filled........ An MRL was
([alpha], [beta] and [gamma]). data for derived in
chronic- ATSDR's 1999
duration oral updated
exposure. toxicological
profile.
28B......... Mechanistic
studies on the
neurotoxicity,
hepatotoxicity,
reproductive
toxicity, and
immunotoxicity
of
hexachlorocyclo
hexane.
[[Page 73764]]
28C......... Exposure levels .............. Filled........ Reference range
in humans concentrations
(adults) living in serum are
near hazardous available (CDC
waste sites and 2005). ATSDR
other acknowledges
populations, that reference
such as exposed concentration
workers. data can
support
exposure and
health
assessments at
waste sites,
but the Agency
also continues
to recognize
the importance
of collecting
additional data
on uniquely
exposed
populations at
waste sites.
28D......... Exposure levels .............. Filled........ Reference range
in children. concentrations
in serum are
available (CDC
2005).
28E......... Potential ATSDR.........
candidate for
subregistry of
exposed persons.
Lead.......................... 29A......... Mechanistic MHPF.......... Filled........ Multiple studies
studies on the (at least 13
neurotoxic publications
effects of lead. from the MHPF
Research
Program +
numerous
studies in
ATSDR's 1999
updated
toxicological
profile) are
available.
29B......... Analytical MHPF.......... Filled........ A publication
methods for from the MHPF
tissue levels. Research
Program and
numerous
studies in
ATSDR's 1999
toxicological
profile are
available.
29C......... Exposure levels MHPF.......... Filled........ In addition to
in humans G. Lakes...... the data from
(adults) near Great Lakes
hazardous waste Research
sites and other Program and
populations, MHPF Research
such as exposed Program,
workers. reference range
concentrations
in blood and
urine are
available (CDC
2005; Paschal
et al. 1998),
and at least 19
ATSDR studies
that evaluated
blood lead
levels and
potential
adverse health
effects are
available.
29D......... Exposure levels .............. Filled........ Reference range
in children. concentrations
in blood and
urine are
available (CDC
2005).
Manganese..................... 30A......... Dose-response MHPF.......... Filled........ Availability of
data for acute- EPA........... studies in the
and MHPF Research
intermediate- Program.
duration oral
exposures (the
subchronic
study should
include
reproductive
histopathology
and an
evaluation of
immunologic
parameters
including
manganese
effects on
plaque-forming
cells (SRBC),
surface markers
(D4:D8 ratio),
and delayed
hypersensitivit
y reactions).
30B......... Toxicokinetic MHPF.......... Filled........ Availability of
studies on EPA........... studies in the
animals to MHPF Research
investigate Program.
uptake and
absorption,
relative uptake
of differing
manganese
compounds,
metabolism of
manganese, and
interaction of
manganese with
other
substances
following oral
exposure.
30C......... Epidemiological .............. Filled........ Based on an
studies on the evaluation of
health effects the data in
of manganese ATSDR's 2000
(Special updated
emphasis end toxicological
points include profile. ATSDR
neurologic, will continue
reproductive, to evaluate new
developmental, data as they
immunologic, become
and cancer). available to
determine if
additional
studies are
needed.
[[Page 73765]]
30D......... Exposure levels
in humans
living near
hazardous waste
sites and other
populations,
such as exposed
workers.
30E......... Relative EPA.
bioavailability
of different
manganese
compounds and
bioavailability
of manganese
from soil.
Mercury....................... 31A......... Multigeneration MHPF.......... Filled........ Availability of
reproductive publications
toxicity study from the MHPF
via oral Research
exposure. Program.
31B......... Dose-response .............. Filled........ An MRL was
data in animals derived in
from chronic- ATSDR's 1999
duration oral updated
exposure. toxicological
profile.
31C......... Immunotoxicology EPA.
battery of
tests via oral
exposure.
31D......... Exposure levels G. Lakes...... Filled........ In addition to
in humans the data from
(adults) living the Great Lakes
near hazardous Research
waste sites and Program,
other background
populations, levels data are
such as exposed available in
workers. ATSDR's 1997
updated
toxicological
profile, and
multiple ATSDR
studies that
evaluated
blood, urine,
hair mercury
levels and
potential
adverse health
effects are
available.
Also, reference
range
concentrations
in blood and
urine are
available (CDC
2005).
31E......... Exposure levels .............. Filled........ Reference range
in children. concentrations
in blood and
urine are
available (CDC
2005).
31F......... Potential ATSDR.
candidate for
subregistry of
exposed persons.
Methoxychlor.................. 32A......... Evaluate .............. Filled........ Based on an
neurologic evaluation of
effects after the data in
long-term, low- ATSDR's 2000
level oral updated
exposure. toxicological
profile.
32B......... Exposure levels
of methoxychlor
and primary
metabolites in
humans living
near hazardous
waste sites and
those
individuals
with the
potential to
ingest it.
32C......... Evaluate the
fate,
transport, and
levels of the
degradation
products of
methoxychlor in
soil.
32D......... Potential ATSDR.
candidate for
subregistry of
exposed persons.
Methylene chloride............ 33A......... Dose-response EPA........... Filled........ ATSDR accepted
data in animals Vol Res....... HSIA's toxicity
for acute- and study for acute-
intermediate- and
duration oral intermediate-
exposure. The duration
subchronic exposure
study should duration in
include February 1997.
extended Also, ATSDR
reproductive accepted HSIA's
organ immunotoxicity
histopathology, study via
neuropathology, inhalation in
and November 2000
immunopathology. and the oral
data obtained
via PBPK
modeling
conducted by
HSIA based on
the
immunotoxicity
data from the
inhalation
study.
Neurotoxicity
screening
battery testing
remains in the
ATSDR/EPA test
rule under
development.
33B......... Prenatal Vol Res....... Filled........ ATSDR accepted
developmental HSIA's study in
toxicity study February 1997.
via the oral
route.
[[Page 73766]]
33C......... Exposure levels .............. Filled........ Reference range
in humans concentrations
living near in blood are
hazardous waste available
sites and other (Ashley et al.
populations, 1992, 1994;
such as exposed Needham et al.
workers. 1995). ATSDR
acknowledges
that reference
concentration
data can
support
exposure and
health
assessments at
waste sites,
but the Agency
also continues
to recognize
the importance
of collecting
additional data
on uniquely
exposed
populations at
waste sites.
33D......... Potential ATSDR.
candidate for
subregistry of
exposed persons.
Nickel........................ 34A......... Epidemilogic .............. Filled........ Based on at
studies on the least two
health effects relevant
of nickel studies in
(Special ATSDR's 1997
emphasis end updated
points include toxicological
reproductive profile. ATSDR
toxicity). will continue
to evaluate new
data as they
become
available to
determine if
additional
studies are
needed.
34B......... Prenatal EPA........... Filled........ In ATSDR's 1997
development updated
toxicity study toxicological
via the oral profile, a
route. study
confirming the
results of two
previous
studies is
available.
34C......... Dose-response EPA.
data in animals
for acute- and
intermediate-
duration oral
exposures.
34D......... Neurotoxicology EPA.
battery of
tests via oral
exposure.
34E......... Bioavailability EPA.
of nickel from
soil.
34F......... Exposure levels G. Lakes...... Filled........ Based on
in humans availability of
(adults) living the data from
near hazardous the Great Lakes
waste sites and Research
other Program and an
populations, evaluation of
such as exposed ATSDR's 1997
workers. updated
toxicological
profile.
34G......... Potential ATSDR.
candidate for
subregistry of
exposed persons.
Pentachlorophenol............. 35A......... Comparative
toxicokinetic
studies.
35B......... Exposure levels .............. Filled........ Reference range
in humans concentrations
(adults) living in urine are
near hazardous available (CDC
waste sites. 2005). ATSDR
acknowledges
that reference
concentration
data can
support
exposure and
health
assessments at
waste sites,
but the Agency
also continues
to recognize
the importance
of collecting
additional data
on uniquely
exposed
populations at
waste sites.
35C......... Exposure levels .............. Filled........ Reference range
in children. concentrations
in urine are
available (CDC
2005).
35D......... Potential ATSDR.
candidate for
subregistry of
exposed persons.
Polychlorinated biphenyls 36A......... Dose-response G. Lakes...... .............. Although an MRL
(PCBs). data in animals for
for acute- and intermediate-
intermediate- exposure
duration oral duration was
exposure. derived in
ATSDR's 2000
updated
toxicological
profile, an MRL
for acute-
exposure
duration is
still lacking.
36B......... Biodegradation
of PCBs in
water;
bioavailability
of PCBs in air,
water, and soil.
[[Page 73767]]
36C......... Dose-response
data in animals
for acute- and
intermediate-
duration
inhalation
exposures. The
subchronic
study should
include
extended
reproductive
organ
histopathology.
36D......... Epidemiologic G. Lakes...... Filled........ In addition to
studies on the the data from
health effects the Great Lakes
of PCBs Research
(Special Program,
emphasis end multiple
points include studies in
immunotoxicity, ATSDR's 2000
gastrointestina updated
l toxicity, toxicological
liver toxicity, profile are
kidney available.
toxicity,
thyroid
toxicity, and
reproductive/
developmental
toxicity).
36E......... Exposure levels G. Lakes...... Filled........ In addition to
in humans the data from
(adults) living the Great Lakes
near hazardous Research
waste sites and Program,
other background
populations, levels data are
such as exposed available
workers. (ATSDR's 1997
updated
toxicological
profile,
Needham et al.
1996, and CDC
2005). Also,
multiple ATSDR
studies that
evaluated blood
and breast milk
PCB levels and
potential
adverse health
effects are
available.
36F......... Exposure levels .............. Filled........ Reference range
in children. concentrations
in serum are
available (CDC
2005).
36G......... Potential ATSDR.
candidate for
subregistry of
exposed persons.
36H \5\..... Chronic toxicity Vol Res....... Filled........ ATSDR accepted
and the final
oncogenicity report of the
via oral GE study in
exposure. October 1997.
36I \5\..... Aerobic PCB Vol Res....... Filled........ ATSDR accepted
biodegradation the final
in sediment. report of the
GE study in
July 1999.
36J \5\..... PCB congener Vol Res....... Filled........ ATSDR accepted
analysis. G. Lakes...... the final
report of the
GE study in
October 1997.
Also, data from
the Great Lakes
Research
Program are
available.
Polycyclic aromatic 37A......... Dose-response MHPF.......... Filled........ MRLs for four
hydrocarbons (PAHs) (Includes data in animals PAHs were
15 substances). for derived in
intermediate- ATSDR's 1995
duration oral updated
exposures. The toxicological
subchronic profile. A
study should publication
include from the MHPF
extended Research
reproductive Program
organ addressing this
histopathology priority data
and need is
immunopathology. available.
37B......... Prenatal MHPF.......... Filled........ Data from the
developmental MHPF Research
toxicity study Program
via inhalation including a
or oral publication are
exposure. available.
37C......... Mechanistic MHPF.......... Filled........ In addition to
studies on publications
PAHs, on how from the MHPF
mixtures of Research
PAHs can Program,
influence the studies are
ultimate available in
activation of ATSDR's 1995
PAHs, and on updated
how PAHs affect toxicological
rapidly profile.
proliferating
tissues.
37D......... Dose-response MHPF.......... Filled........ Data from the
data in animals MHPF Research
for acute- and Program
intermediate- including one
duration publication are
inhalation available.
exposures. The
subchronic
study should
include
extended
reproductive
organ
histopathology
and
immunopathology.
37E......... Epidemiologic .............. Filled........ Multiple studies
studies on the in ATSDR's 1995
health effects updated
of PAHs toxicological
(Special profile are
emphasis end available.
points include ATSDR will
cancer, dermal, continue to
hemolymphatic, evaluate new
and hepatic data as they
toxicity). become
available to
determine if
additional
studies are
needed.
[[Page 73768]]
37F......... Exposure levels G. Lakes...... Filled........ Based on data
in humans from the Great
(adults) living Lakes Research
near hazardous Program and an
waste sites and evaluation of
other the ATSDR 1995
populations, updated
such as exposed toxicological
workers. profile. Also,
reference range
concentrations
in urine are
available (CDC
2005). The
Agency
continues to
recognize the
importance of
collecting
additional data
on uniquely
exposed
populations at
waste sites.
37G......... Exposure levels .............. Filled........ Reference range
in children. concentrations
in urine are
available (CDC
2005).
37H......... Potential ATSDR.
candidate for
subregistry of
exposed persons.
Selenium...................... 38A......... Dose-response EPA.
data in animals
for acute-
duration oral
exposure.
38B......... Immunotoxicology EPA.
battery of
tests via oral
exposure.
38C......... Epidemiologic .............. Filled........ Based on an
studies on the evaluation of
health effects ATSDR's 2001
of selenium updated
(Special toxicological
emphasis end profile. ATSDR
points include will continue
cancer, to evaluate new
reproductive data as they
and become
developmental available to
toxicity, determine if
hepatotoxicity, additional
and adverse studies are
skin effects). needed.
38D......... Exposure levels G. Lakes...... Filled........ In addition to
in humans the data from
living near the Great Lakes
hazardous waste Research
sites and other Program,
populations, reference range
such as exposed concentrations
workers. in serum are
available
(NHANES III).
ATSDR
acknowledges
that reference
concentration
data can
support
exposure and
health
assessments at
waste sites,
but the Agency
also continues
to recognize
the importance
of collecting
additional data
on uniquely
exposed
populations at
waste sites.
38E......... Potential ATSDR.........
candidate for
subregistry of
exposed persons.
1,1,2,2-Tetrachloroethane..... 39A......... Prenatal
developmental
toxicity study
by the oral
route.
39B......... Immunotoxicity
battery
following oral
exposure.
39C......... Mammalian in
vivo
genotoxicity
assays.
39D......... Exposure levels
in humans
living near
hazardous waste
sites.
39E......... Exposure levels
in children.
39F......... Potential ATSDR.........
candidate for
subregistry of
exposed persons.
Tetrachloroethylene........... 40A......... Dose-response .............. Filled........ An MRL was
data in animals derived in the
for acute- ATSDR 1997
duration oral updated
exposure, toxicological
including profile.
neuropathology
and demeanor,
and
immunopathology.
[[Page 73769]]
40B......... Multigeneration Vol Res....... .............. HSIA's
reproductive inhalation
toxicity study study was
via oral accepted by
exposure. ATSDR and
included in
ATSDR's 1997
updated
toxicological
profile.
However, ATSDR
has identified
ingestion of
contaminated
environmental
media to be the
primary
exposure route
for this
chemical at
waste sites.
HSIA will
obtain the oral
data from the
inhalation
study by
conducting PBPK
modeling.
40C......... Dose-response EPA........... HSIA will obtain
data in animals Vol Res....... oral data for
for intermediate-
intermediate- duration
duration oral toxicity and
exposure, neurotoxicity
including by PBPK
neuropathology, modeling based
and on existing
immunopathology. inhalation
data. Also, it
will conduct an
inhalation
immunotoxicity
study, followed
by PBPK
modeling to
obtain oral
data.
40D......... Prenatal Vol Res....... .............. HSIA's
developmental developmental
toxicity study toxicity study
via oral via inhalation
exposure. was accepted by
ATSDR. However,
ATSDR has
identified
ingestion of
contaminated
environmental
media to be the
primary
exposure route
for this
chemical at
waste sites.
HSIA will
obtain the oral
data from the
inhalation
study by
conducting PBPK
modeling.
40E......... Developmental EPA
neurotoxicity Vol Res.......
study via oral
exposure.
40F......... Exposure levels .............. Filled........ Reference range
in humans concentrations
living near in blood are
hazardous waste available
sites and other (Ashley et al.
populations, 1992, 1994;
such as exposed Needham et al.
workers. 1995). ATSDR
acknowledges
that reference
concentration
data can
support
exposure and
health
assessments at
waste sites,
but the Agency
also continues
to recognize
the importance
of collecting
additional data
on uniquely
exposed
populations at
waste sites.
40G......... Potential ATSDR.........
candidate for
subregistry of
exposed persons.
Toluene....................... 41A......... Dose-response .............. Filled........ Availability of
data in animals MRLs for acute-
for acute- and and
intermediate- intermediate-
duration oral exposure
exposures. The durations in
subchronic ATSDR's 2000
study should updated
include an toxicological
extended profile.
histopathologic
evaluation of
the immune
system.
41B......... Comparative .............. Filled........ Based on
toxicokinetic evaluation of
studies the data in
(Characterizati ATSDR's 2000
on of updated
absorption, toxicological
distribution, profile.
and excretion
via oral
exposure).
41C......... Neurotoxicology EPA........... A publication
battery of MHPF.......... for acute
tests via oral exposure but
exposure. not longer term
exposure is
available in
the MHPF
Research
Program. Also,
this priority
data need is
included in the
EPA/ATSDR test
rule.
41D......... Mechanism of .............. Filled........ Multiple studies
toluene-induced in ATSDR's 1994
neurotoxicity. and 2000
updated
toxicological
profiles are
available.
[[Page 73770]]
41E......... Exposure levels .............. Filled........ Reference range
in humans concentrations
living near in blood are
hazardous waste available
sites and other (Ashley et al.
populations, 1992, 1994;
such as exposed Needham et al.
workers. 1995), and
additional data
in ATSDR's 2000
updated
toxicological
profile are
available.
ATSDR
acknowledges
that reference
concentration
data can
support
exposure and
health
assessments at
waste sites,
but the Agency
also continues
to recognize
the importance
of collecting
additional data
on uniquely
exposed
populations at
waste sites.
41F......... Potential ATSDR.........
candidate for
subregistry of
exposed persons.
Toxaphene..................... 42A......... Identify the
long-term
health
consequences of
exposure to
environmental
toxaphene via
oral exposure.
42B......... Conduct
additional
immunotoxicity
studies for
chronic-
duration via
oral route of
exposure.
42C......... Conduct
additional
neurotoxicity
studies for
chronic-
duration via
oral route of
exposure.
42D......... Exposure levels
in humans
living in areas
near hazardous
waste sites
with toxaphene
and in those
individuals
with the
potential to
ingest it.
42E......... Potential ATSDR.........
candidate for
subregistry of
exposed persons.
Trichloroethylene............. 43A......... Dose-response .............. Filled........ An MRL was
data in animals derived in
for acute- ATSDR's 1997
duration oral updated
exposure. toxicological
profile.
43B......... Neurotoxicology EPA .............. A publication
battery of MHPF.......... for acute
tests via the Vol Res....... exposure but
oral route. not longer term
exposure is
available in
the MHPF
Research
Program. Also,
this priority
data need is
included in the
EPA/ATSDR test
rule and
ATSDR's
Voluntary
Research
Program.
43C......... Immunotoxicology Vol Res....... .............. HSIA has
battery of completed an
tests via oral inhalation
route. immunotoxicity
study which is
undergoing
ATSDR peer
review. HSIA
will obtain
oral data via
PBPK modeling
based on the
inhalation
data.
43D......... Prenatal Vol Res....... .............. ATSDR has
developmental accepted HSIA's
toxicity study final report
via oral for an
exposure. inhalation
developmental
toxicity study.
HSIA will use
PBPK modeling
to obtain data
for oral
exposure based
on the results
of its
inhalation
study.
43E......... Developmental EPA
neurotoxicity Vol Res.......
study via oral
exposure.
43F......... Epidemiologic .............. Filled........ Based on
studies on the evaluation of
health effects the data in
of ATSDR's 1997
trichloroethyle updated
ne (Special toxicological
emphasis end profile. ATSDR
points include will continue
cancer, to evaluate new
hepatotoxicity, data as they
renal toxicity, become
developmental available to
toxicity, and determine if
neurotoxicity). additional
studies are
needed.
[[Page 73771]]
43G......... Exposure levels .............. Filled........ Reference range
in humans concentrations
living near in blood are
hazardous waste available
sites and other (Ashley et al.
populations, 1992, 1994;
such as exposed Needham et al.
workers. 1995). ATSDR
acknowledges
that reference
concentration
data can
support
exposure and
health
assessments at
waste sites,
but the Agency
also continues
to recognize
the importance
of collecting
additional data
on uniquely
exposed
populations at
waste sites.
Vinyl chloride................ 44A......... Dose-response .............. Filled........ An MRL was
data in animals derived in
for acute- ATSDR's 1997
duration updated
inhalation toxicological
exposure. profile.
44B......... Multigeneration Vol Res....... Filled........ ATSDR accepted
reproductive the final
toxicity study report of ACC's
via inhalation. study in
November 2000.
44C......... Dose-response
data in animals
for chronic-
duration
inhalation
exposure.
44D......... Mitigation of
vinyl chloride-
induced
toxicity.
44E......... Prenatal Vol Res....... Filled........ ATSDR accepted
developmental the final
toxicity study report of ACC's
via inhalation. study in
November 2000.
44F......... Exposure levels
in humans
living near
hazardous waste
sites and other
populations,
such as exposed
workers.
44G......... Potential ATSDR.
candidate for
subregistry of
exposed persons.
Xylenes....................... 45A......... Dose-response
data for
chronic-
duration
exposure by the
oral route.
This study
should be done
in conjunction
with the
neurotoxicology
battery of
tests.
45B......... Neurotoxicology
battery of
tests following
oral exposure.
45C......... Two-generation
reproductive
study following
oral exposure.
45D......... Developmental
toxicity study
that includes
neurodevelopmen
tal end points
following oral
exposure.
45E......... Exposure levels
in humans
living near
hazardous waste
sites.
45F......... Exposure levels
in children.
45G......... Potential ATSDR.
candidate for
subregistry of
exposed persons.
Zinc.......................... 46A......... Dose-response MHPF.......... Filled........ Availability of
data in animals ongoing studies
for acute- and in the MHPF
intermediate- Research
duration oral Program.
exposures. The
subchronic
study should
include an
extended
histopathologic
evaluation of
the immunologic
and neurologic
systems.
46B......... Multigeneration MHPF.......... Filled........ Availability of
reproductive ongoing studies
toxicity study in the MHPF
via oral Research
exposure. Program.
46C......... Carcinogenicity
testing (2-year
bioassay) via
oral exposure.
46D......... Exposure levels .............. .............. This priority
in humans data need,
living near previously
hazardous waste anticipated to
sites and other be addressed
populations, under the
such as exposed voluntary
workers. research
program, is not
being
investigated
under any of
the ATSDR
research
programs.
[[Page 73772]]
46E......... Potential ATSDR.
candidate for
subregistry of
exposed persons.
----------------------------------------------------------------------------------------------------------------
\1\ Priority data need identification number.
\2\ Programs addressing priority data needs. ATSDR = ATSDR's Division of Health Studies; EPA = U.S.
Environmental Protection Agency; G. Lakes = Great Lakes Human Health Effects Research Program; MHPF = Minority
Health Professions Foundation; NTP = National Toxicology Program; Vol Res = Voluntary research.
\3\ PDN can be filled or remain unchanged based on reevaluation of the database using criteria developed by
ATSDR.
\4\ ACC = American Chemistry Council; Ashley et al. 1992 = Ashley DL, Bonin MA, Cardinali FL, et al. Anal Chem
(1992) 64:1021-29; Ashley et al. 1994 = Ashley DL, Bonin MA, Cardinali FL et al., Clin Chem (1994) 40/7:1401-
4; ATSDR studies = Studies conducted by ATSDR's Division of Health Studies; GE = General Electric Company;
HSIA = Halogenated Solvents Industry Alliance, Inc.; MHPF = Minority Health Professions Foundation; MRL =
Minimal Risk Level; CDC 2005 = The third National Report on Human Exposure to Environmental Chemicals,
prepared by the National Center for Environmental Health, Centers for Disease Control and Prevention, Atlanta,
GA; Needham et al. 1995 = Needham LL, Hill RH Jr, Ashley DL, Pirkle JL, and Sampson EJ. Environ Health
Perspect 103(Suppl 3):89-94; Needham et al. 1996 = Needham LL, Patterson DG Jr, Burse VW, Paschal DC, Turner
WE, and Hill VW Jr. Toxicol Ind Health 12:507-513; NHANES III = The Third National Health and Nutrition
Examination Survey, conducted by the National Center for Health Statistics, Centers for Disease Control and
Prevention, Atlanta, GA; NTP = National Toxicology Program; Paschal et al. 1998 = Paschal DC, Ting BC, Morrow
JC, et al. Environ Res, Section A 76: 53-59; PBPK modeling = physiologically based pharmacokinetic modeling;
Toxicological profile = ATSDR's toxicological profiles for the Agency's priority hazardous substances.
\5\ Not a priority data need.
Table 2.--Groups Which Are Addressing/Have Addressed ATSDR's Substance-Specific Priority Data Needs (PDNs)
----------------------------------------------------------------------------------------------------------------
Firm, institution,
Program agency, or consortium Substance PDN ID
----------------------------------------------------------------------------------------------------------------
Voluntarism....................... American Chemistry Vinyl chloride...... 44B, 44E
Council.
General Electric PCBs................ 36H*, 36I*, 36J*
Company.
Halogenated Solvents Methylene chloride.. 33A, 33B
Industry Alliance,
Inc.
Tetrachloroethylene. 40B, 40C, 40D, 40E
Trichloroethylene... 43B, 43C, 43D, 43E
Minority Health Professions Florida A & M Lead................ 29A
Foundation. University.
The King/Drew Medical Lead................ 29B, 29C
Center of the
Charles R. Drew
University of
Medicine and Science.
Meharry Medical PAHs................ 37A, 37B, 37C, 37D
College.
Morehouse School of Lead................ 29C
Medicine.
Texas Southern Di-n-butyl phthalate 21D
University.
Lead................ 29A
Toluene............. 41C
Trichloroethylene... 43B
Tuskegee University.. Chlordane........... 9A
Mercury............. 31A
Zinc................ 46A, 46B
Xavier University.... Manganese........... 30A, 30B
Zinc................ 46A
Great Lakes Human Health Effects Michigan State DDT/DDE............. 19D, 19E
Research Program. University.
Lead................ 29C
Mercury............. 31D
PCBs................ 36D, 36E, 36J*
Selenium............ 38D
New York State Health DDT/DDE............. 19E
Department.
Lead................ 29C
Mercury............. 31D
PCBs................ 36D, 36E, 36J*
State University of PCBs................ 36E
New York at Albany.
State University of DDT/DDE............. 19D, 19E
New York at Buffalo.
Lead................ 29C
Mercury............. 31D
PCBs................ 36D, 36E, 36J*
State University of DDT/DDE............. 19D, 19E
New York at Oswego.
Lead................ 29C
Mercury............. 31D
PCBs................ 36D, 36E, 36J*
University of DDT/DDE............. 19D, 19E
Illinois at Chicago.
[[Page 73773]]
Lead................ 29C
Mercury............. 31D
PCBs................ 36D, 36E, 36J*
University of DDT/DDE............. 19D, 19E
Illinois at Urbana-
Champaign.
Lead................ 29C
Mercury............. 31D
PCBs................ 36D, 36E, 36J*
University of DDT/DDE............. 19D, 19E
Wisconsin-Milwaukee.
Lead................ 29C
Mercury............. 31D
PCBs................ 36A, 36D, 36E, 36J*
Selenium............ 38D
Wisconsin Department Arsenic............. 2D
of Health and Social
Services--5 State
Consortium.
Cadmium............. 7B
Chromium............ 13E
DDT/DDE............. 19D, 19E
Lead................ 29C
Mercury............. 31D
Nickel.............. 34F
PAHs................ 37F
PCBs................ 36D, 36E, 36J*
Environmental Protection Agency EPA/ATSDR Test Rule.. Benzene............. 4A, 4B, 4C
TSCA/FIFRA.
Chloroethane........ 11A, 11B
Cyanide (hydrogen 14A, 14B
cyanide and sodium
cyanide).
Methylene chloride.. 33A
Tetrachloroethylene. 40C, 40E
Toluene............. 41C
Trichloroethylene... 43B, 43E
Metals Testing Task Arsenic............. 2A, 2B, 2C
Force (TASARC).
Beryllium........... 6A, 6B, 6C, 6E
Chromium............ 13A, 13B, 13C, 13D
Manganese........... 30A, 30B, 30E
Mercury............. 31C
Nickel.............. 34B, 34C, 34D, 34E
Selenium............ 38A, 38B
National Toxicology Program....... National Institute of Carbon tetrachloride 8B
Environmental Health
Sciences.
1,1-dichloroethene.. 18A, 18B
Di-n-butyl phthalate 21A
Disulfoton.......... 22A
Heptachlor.......... 26B
----------------------------------------------------------------------------------------------------------------
* Not priority data needs.
Editorial Note: FR Doc. 05-23361 was originally published at
page 71506 in the issue of Tuesday, November 29, 2005. The corrected
document is republished in its entirety, due to printing errors.
[FR Doc. R5-23361 Filed 12-12-05; 8:45 am]
BILLING CODE 1505-01-D