[Federal Register Volume 64, Number 10 (Friday, January 15, 1999)]
[Notices]
[Pages 2760-2790]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-971]
[[Page 2759]]
_______________________________________________________________________
Part VI
Department of Health and Human Services
_______________________________________________________________________
Agency for Toxic Substances and Disease Registry
_______________________________________________________________________
Update on the Status of the Superfund Substance-Specific Applied
Research Program; Notice
Federal Register / Vol. 64, No. 10 / Friday, January 15, 1999 /
Notices
[[Page 2760]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Toxic Substances and Disease Registry
[ATSDR-140]
Update on the Status of the Superfund Substance-Specific Applied
Research Program
AGENCY: Agency for Toxic Substances and Disease Registry (ATSDR),
Department of Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
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 1996 (61 FR 14420). 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 (62 FR 61332, November 17, 1997), 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.
To date, 124 priority data needs have been identified for the first
set of 38 hazardous substances, and 64 priority data needs have been
identified for the second set of 12 hazardous substances. ATSDR fills
these data needs through regulatory mechanisms (test rules), private-
sector voluntarism, and the direct use of CERCLA funds. Additional data
needs are being addressed through an interagency agreement with the
National Toxicology Program (NTP), by ATSDR's Great Lakes Human Health
Effects Research Program, and other agency programs. To date, 79
priority data needs associated with the first set of 38 priority
substances (Table 1), and 23 priority data needs associated with the
second set of 12 priority substances (Table 2) are being addressed via
these mechanisms.
Table 1 also shows the progress ATSDR has made in filling research
needs for the first set of 38 hazardous substances. On the basis of
criteria developed by ATSDR, 14 priority data needs and 2 data needs
have been filled, 26 priority data needs have been reclassified as data
needs, and 2 additional priority data needs and 1 data need are
considered conditionally filled pending ATSDR peer review of the final
reports.
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, NTP, and the Environmental Protection Agency (EPA), will
review all proposed voluntary research efforts.
DATES: ATSDR provides updates on the status of its Substance-Specific
Applied Research Program approximately every 3 years. 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 may write to Dr. William Cibulas, Chief, Research
Implementation Branch, Division of Toxicology, ATSDR, 1600 Clifton
Road, NE., Mailstop E-29, Atlanta, Georgia 30333. Information about
pertinent ongoing or completed research that may fill priority data
needs cited in this Notice should be similarly addressed.
FOR FURTHER INFORMATION CONTACT: Dr. William Cibulas, Chief, Research
Implementation Branch, Division of Toxicology, ATSDR, 1600 Clifton
Road, NE., Mailstop E-29, Atlanta, Georgia 30333, telephone 404-639-
6306.
SUPPLEMENTARY INFORMATION:
Background
CERCLA as amended by SARA (42 U.S.C. 9604(i)) requires that ATSDR
(1) jointly with the EPA, develop and 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 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 (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 to conduct comprehensive public health assessments of
populations living near hazardous waste sites. We anticipate that 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. 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.
On October 17, 1991, ATSDR announced the identification of the
priority data needs for 38 priority hazardous substances (56 FR 52178),
requested public comments, and invited private-sector organizations to
volunteer to conduct research to address specific priority data needs.
On November 16, 1992, the agency published a revised list of 117
priority data needs for these hazardous substances (57 FR 54150). Since
1992, the total number of priority
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data needs for the 38 substances has increased from 117 to 124 because
the database was reevaluated (Table 1). The 7 additional priority data
needs consist of 5 substances now considered as candidates for
subregistries of exposed persons (determined by the ATSDR Division of
Health Studies; the priority data needs for nickel, PCBs, toluene, and
zinc were added in 1996, and that for beryllium was added in 1998), and
2 new priority data needs for trichloroethylene.
Regarding the 2 additional priority data needs for
trichloroethylene, the need for intermediate-duration oral exposure
data resulted from the withdrawal of the corresponding minimal risk
level (MRL, a health guidance value) from the 1997 ATSDR updated
Toxicological Profile for Trichloroethylene (Table 1). The other new
priority data need for trichloroethylene is for a 1-species
developmental toxicity study with emphasis on developmental
neurotoxicity. Recent reports in humans, together with findings in
animals, suggest that developmental effects may be the most sensitive
end point for trichloroethylene.
Therefore, the proposed study may provide more definitive
information on dose-response relationships for these effects and more
fully characterize the potential for adverse health outcome in the
developing fetus.
Two additional changes from the 1992 list of priority data needs
have been made for tetrachloroethylene. The priority data need for
chronic-duration oral exposure data has been replaced by the need for
intermediate-duration oral exposure data because of the withdrawal of
the intermediate-duration oral MRL from the 1997 ATSDR updated
Toxicological Profile for Tetrachloroethylene (Table 1). ATSDR
considers it is more appropriate to obtain intermediate-duration data
before assigning priority to the conduct of chronic-duration studies.
With regard to the priority to obtain developmental toxicity data, the
use of 1-species (instead of the previously recommended 2-species) in
the study is now considered adequate based on reevaluation of the
database.
Table 1 also includes 3 PCB research needs that are not considered
``priority'' but were filled via voluntary research (see PDN ID#s 7G,
7H, and 7I).
On July 30, 1997, 77 priority data needs for 12 additional priority
hazardous substances were determined and announced in the Federal
Register (62 FR 40820). At that time, the 77 priority data needs
included the need to evaluate existing data on concentrations of all 12
substances in environmental media at hazardous waste sites. The agency
continues to recognize the need to collect, evaluate, and interpret
such data, but no longer considers these ``priority.'' This is because
a substantial amount of this information has already been collected
through individual state programs and the EPA's CERCLA activities.
Further, an ongoing effort at the agency is to evaluate the extant
information from these programs to better characterize the need for
additional site-specific information. Finally, during a recent
reevaluation of potential candidates for subregistries of exposed
persons conducted by ATSDR, manganese was removed from the candidate
pool; consequently, this priority data need was reclassified as a data
need. Therefore, the current total number of priority data needs
associated with the second set of 12 priority substances is now 64
(Table 2).
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 substances under TSCA and
by registrants under the Federal Insecticide, Fungicide, and
Rodenticide Act of 1972 (FIFRA), or by cost recovery from responsible
parties under CERCLA. To execute this statutory intent, ATSDR developed
a plan whereby parts of the SSARP are being conducted via regulatory
mechanisms (TSCA/FIFRA), private-sector voluntarism, and the direct use
of CERCLA funds.
The TASARC, composed of scientists from ATSDR, 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 eight times since the initiation of the SSARP. It
has guided referral of 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 agenda. 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 it has endorsed the use of decision support
methodologies such as physiologically based pharmacokinetic (PBPK)
modeling and benchmark-dose modeling, where appropriate.
Additional data needs are being addressed through an interagency
agreement with NTP, by ATSDR's Great Lakes Human Health Effects
Research Program, and other agency programs. To date, 79 priority data
needs associated with the first set of 38 priority substances (Table
1), and 23 priority data needs associated with the second set of 12
priority substances (Table 2) are being addressed via these mechanisms.
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 may be filled, reclassified as a data need, or unchanged.
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 have not been included in the
original list of priority data needs. In such cases, additional data
needs or priority data needs may be added to the research agenda.
The criteria for evaluating the status of the priority data needs
are described below.
General Criteria
1. A priority data need is filled:
If a study, specifically designed to address a priority
data need and conducted via any of the ATSDR implementation mechanisms,
has been completed and published in a peer-reviewed journal, or has
been accepted by ATSDR based on the recommendations of the agency's
peer reviewers, or
If an updated ATSDR toxicological profile or other recent
review document contains relevant new (peer reviewed and publicly
available) studies since the finalization of the priority data needs
document; and it is generally agreed that a priority data need no
longer exists.
Note: Priority data needs documents that describe ATSDR's
rationale for prioritizing research needs for each substance in
Tables 1 and 2 are available. See ADDRESSES section of this Notice.
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2. A priority data need is reclassified as a data need:
If an updated ATSDR toxicological profile or other recent
review document contains relevant new (peer reviewed and publicly
available) studies since the finalization of the priority data needs
document; however, in the data needs section of the toxicological
profile, a need for additional data to fully characterize the end point
is still identified, or
If a study addressing a priority data need has been
reviewed by members of the Tri-Agency Superfund Applied Research
Committee and it is agreed that a data need still exists although it is
no longer a priority (See priority data need ``Evaluation of the
environmental fate of cyanide in soil'' in Table 1), or
For any substance whose overall rank on the ATSDR Priority
List of Hazardous Substances falls below 275.
3. A priority data need is unchanged:
If no mechanism or information has been identified to
address the priority data need, or
If the ATSDR toxicological profile has not been updated
since the finalization of the priority data needs document (Exception:
See Section ``Specific Criteria'' for the priority data need ``Exposure
levels in humans''), or
If the priority data need is included in the ATSDR test
rule under development, or
If ongoing discussions between ATSDR and a private-sector
organization indicate that the priority data need is a candidate to be
addressed via the voluntary research program, or
If a study, specifically designed to address a priority
data need and conducted via any of the ATSDR implementation mechanisms,
is ongoing.
Specific Criteria
1. Priority data need, ``Inhalation and/or oral dose-response data
for acute, intermediate, and/or chronic duration.''
These priority data needs are filled if minimal risk levels (MRLs)
have been derived in the updated ATSDR toxicological profile since the
finalization of the priority data needs document. However, in certain
cases where the database (from which an MRL is derived) is sparse, a
data need may still be identified in the toxicological profile to
increase the confidence in the MRL.
2. Priority data need, ``Exposure levels in humans.''
This priority data need is considered filled if there are reference
range data (e.g., National Health and Nutrition Examination Survey
[NHANES]) or generally agreed upon background population levels AND if
there are current and adequate biomonitoring data for exposed
populations associated with health effects (from published or ongoing
studies).
This priority data need is reclassified as a data need if only one
of the following 2 criteria is met: (1) There are reference range data
or generally agreed upon background population levels OR (2) if there
are current and adequate biomonitoring data for exposed populations
associated with health effects (from published or ongoing studies).
3. Priority data need ``Mechanism of toxic action.''
This priority data need is considered filled if there is scientific
consensus indicating that the mechanism(s) of toxic action is well
characterized.
This priority data need is reclassified as a data need if an
updated toxicological profile contains relevant new (peer reviewed and
publicly available) studies since the finalization of the priority data
needs document; however, the database may not be sufficient to achieve
scientific consensus on the mechanism of toxic action.
Based on the above criteria, the status of the research needs for
the first set of 38 priority substances was evaluated (Table 1). To
date, 14 priority data needs and 2 data needs have been filled, 26
priority data needs have been reclassified as data needs, and 2
additional priority data needs (Table 1, vinyl chloride, PDN ID #4B and
4E) and 1 data need (Table 1, PCBs, PDN ID #7H) are considered
conditionally filled pending ATSDR peer review of the final reports.
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, NTP, and EPA
identified priority data needs for substances on the TSCA inventory of
mutual interest to the federal programs. These data needs are being
addressed through a program of toxicologic 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 is considering proposals to
conduct inhalation studies in conjunction with physiologically based
pharmacokinetic (PBPK) studies in lieu of oral bioassays. ATSDR expects
that inhalation data derived from these studies can be used with PBPK
modeling to address its oral toxicity data needs. Currently, an EPA/
ATSDR test rule, under development, includes 7 ATSDR substances, i.e.,
benzene, chloroethane, cyanide (including hydrogen cyanide and sodium
cyanide), methylene chloride, tetrachloroethylene, trichloroethylene,
and toluene, and addresses 15 priority data needs (Table 3). The test
rule was reviewed by ATSDR and is undergoing EPA final review. It will
be available for public comment in the near future.
TASARC has established an interagency task force on metals and has
recently conducted a survey to assess federal agencies' needs for
testing metals. Currently, the task force has agreed to examine at
least 7 metals included in the ATSDR's SSARP (arsenic, beryllium,
chromium, manganese, mercury, nickel, and selenium, associated with 22
priority data needs) (Table 3). The EPA will solicit testing proposals
for these metals and pursue test rule development for these metals at a
later date.
B. Private-Sector Voluntarism
As part of the SSARP, on February 7, 1992, ATSDR announced a set of
proposed procedures for conducting voluntary research (57 FR 4758).
Revisions based on public comments were published on November 16, 1992
(57 FR 54160). Private-sector organizations were encouraged to
volunteer to conduct research to address specific priority data needs.
ATSDR currently has memoranda of understanding (MOUs) in place with
the General Electric Company (GE), the Halogenated Solvents Industry
Alliance (HSIA), and the Chemical Manufacturers Association (CMA)
(Table 3). Through the voluntary research efforts of these
organizations, 12 research needs for two classes of substances
(polychlorinated biphenyl compounds [PCBs] and volatile organic
compounds, including methylene chloride, tetrachloroethylene,
trichloroethylene, and vinyl chloride) are being addressed (Table 3).
Recently, the agency received a study protocol from the Counselors
for Management, Inc., on behalf of a spectrum of the zinc industry
which is considering to conduct research to address ATSDR's priority
data needs for zinc. This represents the first study proposed by a
private-sector organization to address priority data needs for a metal.
Voluntary research covered under the three existing MOUs is described
next.
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General Electric Company
In 1995, ATSDR entered into an MOU with GE. This marked the first
time a private-sector organization had volunteered to conduct research
to address data needs identified in ATSDR's SSARP. The MOU with GE
covers two studies on PCBs: (1) ``An assessment of the chronic toxicity
and oncogenicity of Aroclors 1016, 1242, 1254, and 1260 administered in
diet to rats,'' including ``PCB congener analyses,'' and (2)
``Metabolite detection as a tool for determining naturally occurring
aerobic PCB biodegradation.'' While the above studies do not address
ATSDR's priority data needs for PCBs, they do address other agency
research needs for these substances.
The agency accepted the final report for the first study (chronic
toxicity and oncogenicity) in October 1997. The study provided an in-
depth understanding of the relative toxicity of the prevalent
commercial mixtures of PCBs (Aroclor 1016, Aroclor 1242, Aroclor 1254,
and Aroclor 1260) after long-term exposures. The investigators found
exposure-related toxicity for all four Aroclors. Furthermore, the study
includes characterization of PCB composition, tissue accumulation, and
correlations with tumorigenicity in chronically dosed rats. With regard
to the second GE study (aerobic PCB biodegradation), also covered under
the MOU, the final report is being evaluated by ATSDR's peer reviewers.
The acceptance of the final report will be based on the recommendations
of the reviewers and GE's satisfactory response to the reviewers'
comments.
Halogenated Solvents Industry Alliance (HSIA)
In 1995, ATSDR entered into an MOU with HSIA covering studies to
address three priority toxicity data needs for methylene chloride. The
studies, ``Addressing priority data needs for methylene chloride with
physiologically based pharmacokinetic modeling,'' evaluated acute- and
subchronic-duration toxicity via oral exposures and developmental
toxicity via oral exposure. The data were obtained by using
physiologically based pharmacokinetic modeling.
The final report for these studies, the first one to be completed
under the voluntary research program, was accepted by the agency in
February 1997. The HSIA studies indicated that adverse health effects
on the central nervous system, liver, and the development of newborns
may occur if people drink water containing high concentrations of
methylene chloride (565 to 6,170 milligrams methylene chloride per
liter of water). These amounts are much larger than what most people
are exposed to in the environment. However, these amounts approach
levels found at industrial sites and in waste waters (ATSDR's
Toxicological Profile for Methylene Chloride, 1993). HSIA has also
proposed to conduct an immunotoxicity assessment for methylene chloride
via inhalation exposure. The agency expects to receive a study protocol
from HSIA for peer review in the near future.
In addition, ATSDR and HSIA are continuing negotiation to expand
the existing MOU to include research on trichloroethylene and
tetrachloroethylene.
Chemical Manufacturers Association (CMA)
In 1996, ATSDR entered into an MOU with CMA covering two studies,
``Vinyl chloride: Combined inhalation two-generation reproduction and
developmental toxicity study in CD rats.'' Recently, the ATSDR peer
review of the final report on the developmental toxicity study was
completed. The final report for the reproductive toxicity study is
undergoing ATSDR peer review. Acceptance of the final reports is based
on the reviewers' recommendations and CMA's satisfactory response to
the reviewers' comments.
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 501(c)(3)
organization, the MHPF comprises 11 minority health professions
schools. Its primary mission is to research the health problems that
disproportionately affect poor and minority citizens. The purpose of
this cooperative agreement is to address substance-specific data needs
for priority hazardous substances identified by ATSDR. In addition,
this agreement strengthens the environmental health research
opportunities for scientists and students at MHPF member institutions
and enhances existing disciplinary capacities to conduct research in
toxicology and environmental health.
In the first 5-year project period that concluded during FY 1997, 9
priority data needs for 21 priority hazardous substances and 22 data
needs for these and other substances were addressed. The MHPF has
developed 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. New research
initiated in the second 5-year project period includes studies to
address 10 additional priority data needs for chlordane, 1,2-dibromo-3-
chloropropane, di-n-butyl phthalate, lead, manganese, the polycyclic
aromatic hydrocarbons (PAHs), and zinc, and another 8 data needs.
To date, the MHPF activities have resulted in the publication of 21
manuscripts in peer-reviewed journals. Findings from this program were
presented at a symposium held in April 1997, in New Orleans. Also,
these and other research findings from the program were featured in a
special session during the 1998 annual meeting of the Society of
Toxicology in Seattle. The institutions receiving awards and their
respective research projects are listed in Table 3.
D. National Toxicology Program (NTP)
ATSDR maintains an interagency agreement (IAG) with NTP to conduct
toxicologic testing of substances identified at NPL sites. The studies
determine levels of exposure that present a significant risk to humans
of acute, subchronic, and chronic health effects. Often these studies
include an assessment of the substance's ability to cause cancer,
reproductive toxicity, and birth defects. The results of these studies
are used by regulatory agencies, various environmental and industrial
groups, and ATSDR to improve its ability to conduct public health
assessments at NPL sites.
Under this agreement, one toxicity priority data need identified in
the SSARP (immunotoxicology study of carbon tetrachloride) was filled
(Table 1). Research efforts to address reproductive toxicity data needs
for chlordane, endrin, and heptachlor, the bioavailability of PCBs in
soil, and dose-response data for di-n-butyl phthalate are also ongoing
(Table 3).
During FY 1993, the existing IAG was modified to include toxicity
studies of ATSDR's priority hazardous substances via application of
structure-activity relationship (SAR) techniques, PBPK modeling, and
functional toxicity testing. The ATSDR-supported NTP studies in these
areas are ongoing.
E. Great Lakes Human Health Effects Research Program
Some of the priority data needs identified in the SSARP have been
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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 FY 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 further define the
human health consequences of exposure to persistent toxic substances
(PTSs) identified in the Great Lakes basin. These at-risk populations
include sport anglers, Native Americans, pregnant women, fetuses and
nursing infants of mothers who consume contaminated Great Lakes fish,
infants and children, the elderly, and the urban poor.
To date, the research activities of the ATSDR Great Lakes research
program have resulted in 22 manuscripts in peer-reviewed journals. An
additional 13 manuscripts have been accepted for publication and will
soon be in press. Research findings from this program have been
presented at 8 international conferences and various scientific
meetings and symposia.
Currently, 13 priority data needs and 1 data need for 24 priority
hazardous substances (including 15 PAHs) identified in the SSARP are
being addressed through this program. The institutions receiving awards
and their respective studies are listed in Table 3.
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 37 of the first set of 38 priority substances
(Table 1). Similarly, this priority data need has been identified for
all 12 of the second set of 12 priority substances. ATSDR will obtain
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.
The list of 50 priority hazardous substances in the SSARP was
forwarded to ATSDR's Exposure and Disease Registry Branch (EDRB),
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. To date,
of the first set of 38 priority substances in the SSARP, ATSDR has
selected benzene, chromium, and trichloroethylene as primary
contaminants to establish subregistries in the National Exposure
Registry. However, aldrin/dieldrin, beryllium, carbon tetrachloride,
chloroethane, chloroform, cyanide, p,p'-DDT, DDE, DDD, di(2-
ethylhexyl)phthalate, mercury, methylene chloride, nickel, PAHs, PCBs,
selenium, tetrachloroethylene, toluene, vinyl chloride, and zinc remain
in the candidate pool and therefore continue to be classified as
priority data needs. They will be considered for selection as primary
contaminants during each selection process (Table 1). Arsenic, cadmium,
and lead are not considered to be in the pool of candidate substances
for an exposure registry at this time, and therefore, are not
considered priority data needs. This decision will be reevaluated as
more information on the chemicals and exposure sites become available.
Regarding the second set of 12 priority substances, all of them
were included in the candidate pool for establishment of exposure
subregistries (i.e., priority data needs, published in the 1996 Federal
Register Notice [61 FR 14430]). However, during a recent reevaluation
of the database, manganese was removed from the candidate pool, and
therefore, this priority data need for manganese has been reclassified
as a data need, and is not included in Table 2.
The results of the research conducted via the SSARP will be used
for public health assessments and to reassess ATSDR's substance-
specific priority data needs. The agency expects to provide an update
on the status of this research program every three years.
Dated: January 11, 1999.
Georgi Jones,
Director, Office of Policy and External Affairs, Agency for Toxic
Substances and Disease Registry.
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[FR Doc. 99-971 Filed 1-14-99; 8:45 am]
BILLING CODE 4163-70-C
