[Federal Register Volume 66, Number 157 (Tuesday, August 14, 2001)]
[Notices]
[Pages 42659-42663]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-20373]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Toxic Substances and Disease Registry
[ATSDR-172]
Identification of Priority Data Needs for 10 Priority Hazardous
Substances
AGENCY: Agency for Toxic Substances and Disease Registry (ATSDR), U.S.
Department of Health and Human Services (HHS).
ACTION: Request for public comments on the identification of priority
data needs for 10 priority hazardous substances, and an ongoing call
for voluntary research proposals.
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SUMMARY: This Notice makes available for public comment the priority
data needs for 10 priority hazardous substances (see attached Table 1)
as part of the continuing development and implementation of the ATSDR
Substance-Specific Applied Research Program (SSARP). The Notice also
serves as a continuous call for voluntary research proposals. The SSARP
is authorized by the Comprehensive Environmental Response,
Compensation, and Liability Act of 1980 (Superfund) or CERCLA, and
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 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). In
1997, ATSDR finalized the priority data needs for a second list of 12
substances that was subsequently announced in the Federal Register (62
FR 40820).
Ten substances constitute the third list of hazardous substances
for which priority data needs have been identified by ATSDR. In
developing this list, ATSDR solicited input from the Environmental
Protection Agency (EPA) and the National Institute of Environmental
Health Sciences (NIEHS). The priority data needs documents are
available for review by requesting them in writing from ATSDR (see
ADDRESSES section of this Notice).
The exposure and toxicity priority data needs in this Notice were
distilled from data needs identified in the agency's toxicological
profiles via a logical scientific approach described in a ``Decision
Guide published'' in the Federal Register on September 11, 1989 (54 FR
37618). The priority data needs represent essential information to
improve the database to conduct public health assessments. Research to
address these data needs will help determine the types or levels of
exposure that may present significant risks of adverse health effects
in people exposed to the subject substances.
The priority data needs identified in this Notice reflect the
opinion of the agency, in consultation with other federal programs, of
the research needed pursuant to ATSDR's authority under CERCLA. They do
not represent the priority data needs for any other program.
Consistent with Section 104(i)(12) of CERCLA as amended [42 U.S.C.
9604(i)(12)], nothing in this research program shall be construed to
delay or otherwise affect or impair the authority of the President, the
Administrator of ATSDR, or the Administrator of EPA to exercise any
authority regarding any other provision of law, including the Toxic
Substances Control Act of 1976 (TSCA) and the Federal Insecticide,
Fungicide, and Rodenticide Act of 1972 (FIFRA), or the response and
abatement authorities of CERCLA.
In developing this research program, ATSDR has worked with other
federal programs to determine common substance-specific data needs, as
well as mechanisms to implement research that may include authorities
under TSCA and FIFRA, private-sector voluntarism, or the direct use of
CERCLA funds.
When deciding the type of research that should be done, ATSDR
considers the recommendations of the Interagency Testing Committee
established under Section 4(e) of TSCA. Federally funded projects that
collect information from 10 or more respondents and that are funded by
cooperative agreements are subject to review by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act. If the
proposed project involves research on human subjects, the applicants
must comply with Department of Health and Human Services regulations
(45 CFR part 46) regarding the protection of human subjects. Assurance
must be provided that the project will be subject to initial and
continuing review by the appropriate institutional review committees.
Overall, data generated from this research program will lend support to
others conducting human health assessments involving these 10
substances by providing additional scientific information for the risk
assessment process.
The 10 substances, which are included in the ATSDR Priority List of
Hazardous Substances established by
[[Page 42660]]
ATSDR and EPA (64 FR 56792, October 21, 1999), are:
Asbestos
Benzidine
Chlorinated dibenzo-p-dioxins
1,2-dibromoethane
1,2-dichloroethane
1,1-dichloroethene
Ethylbenzene
Pentachlorophenol
1,1,2,2-tetrachloroethane
Total xylenes
The priority data needs for these 10 substances are presented in
Table 1. We invite comments from the public on individual data needs.
After considering the comments, ATSDR will publish the final priority
data needs for each substance. These priority data needs will be
addressed by the mechanisms described in the ``Implementation of
Substance-Specific Applied Research Program'' section of this Federal
Register Notice.
This Notice also serves as a continuous call for voluntary research
proposals. Private-sector organizations may volunteer to conduct
research to address specific priority data needs in this Notice by
indicating their interest through submission of a letter of intent to
ATSDR (see ADDRESSES section of this Notice). A Tri-Agency Superfund
Applied Research Committee (TASARC) comprised of scientists from ATSDR,
the National Toxicology Program (NTP), and EPA will review all
proposals.
The substance-specific priority data needs were based on, and
determined from, information in corresponding ATSDR toxicological
profiles. Background technical information and justification for the
priority data needs in this Notice are in the priority data needs
documents. These documents are available for review by requesting them
in writing from ATSDR (see ADDRESSES section of this Notice).
DATES: Comments concerning the priority data needs for the 10
substances must be received by November 13, 2001. Regarding ATSDR's
call for voluntary research proposals, the agency considers the
voluntary research effort to be crucial to the continuing development
of the Substance-Specific Applied Research Program, and believes this
effort should be an open and continuous one. Therefore, private-sector
organizations are encouraged to volunteer to conduct research to
address identified data needs, beginning with the publication of this
Notice and until that time when ATSDR announces that other research has
been initiated for a specific data need.
ADDRESSES: Submit comments to Dr. William Cibulas, Chief, Research
Implementation Branch, Division of Toxicology, ATSDR, 1600 Clifton
Road, NE., Mailstop E-29, Atlanta, GA 30333. Use the same address for
requests for priority data needs documents and submission of proposals
to conduct voluntary research.
Comments on this Notice will be available for public inspection at
ATSDR, Building 4, Suite 2400, Executive Park Drive, Atlanta, Georgia
(not a mailing address), from 8 a.m. to 4:30 p.m., Monday through
Friday, except for legal holidays.
FOR FURTHER INFORMATION CONTACT: Dr. William Cibulas, Chief, Research
Implementation Branch, Division of Toxicology, ATSDR, 1600 Clifton
Road, NE., Mailstop E-29, Atlanta, GA 30333, telephone (404) 498-0140.
SUPPLEMENTARY INFORMATION:
Background
The Comprehensive Environmental Response, Compensation, and
Liability Act of 1980 (Superfund) or CERCLA, as amended by the
Superfund Amendments and Reauthorization Act of 1986 (SARA) [42 U.S.C.
9604(i)], requires that ATSDR (1) develop jointly with EPA a list of
hazardous substances found at National Priorities List (NPL) sites (in
order of priority), (2) prepare toxicological profiles of these
substances, and (3) assure the initiation of a research program to
address identified priority data needs associated with the substances.
The Substance-Specific Applied Research Program (SSARP) was
initiated on October 17, 1991. At that time, a list of priority data
needs for 38 priority hazardous substances 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). In 1997, ATSDR finalized the priority data needs for a second
list of 12 substances and announced the list in the Federal Register
(62 FR 40820). Currently, a total of 201 priority data needs have been
identified for these 50 substances.
This ATSDR SSARP supplies necessary information to improve the
database to conduct public health assessments. This link between
research and public health assessments, and the process for distilling
priority data needs for ranked hazardous substances from data needs
identified in associated ATSDR toxicological profiles, are described in
the ATSDR ``Decision Guide for Identifying Substance-Specific Data
Needs Related to Toxicological Profiles'' (54 FR 37618, September 11,
1989).
Implementation of Substance-Specific Applied Research Program
In Section 104(i)(5)(D), CERCLA states that it is the sense of
Congress that the costs for conducting this research program be borne
by the manufacturers and processors of the hazardous substances under
the Toxic Substances Control Act of 1976 (TSCA) and by registrants
under the Federal Insecticide, Fungicide, and Rodenticide Act of 1972
(FIFRA), or by cost recovery from responsible parties under CERCLA. To
execute this statutory intent, ATSDR developed a plan whereby parts of
the SSARP are being conducted via regulatory mechanisms (TSCA/FIFRA),
private-sector voluntarism, and through the direct use of CERCLA funds.
CERCLA also requires that ATSDR consider recommendations of the
Interagency Testing Committee (ITC), established under Section 4(e) of
TSCA, on the types of research to be done. ATSDR actively participates
on this committee; however, none of the proposed 10 substances are now
on the ITC priority testing list.
The mechanisms for implementing the SSARP are discussed next. The
status of the SSARP in addressing priority data needs of the first 50
priority hazardous substances via these mechanisms was described in a
Federal Register Notice on January 15, 1999 (64 FR 2760).
A. TSCA/FIFRA
In developing and implementing the SSARP, ATSDR and EPA established
procedures to identify those priority data needs of common interest to
multiple federal programs. Where practicable, these data needs will be
addressed through a program of toxicologic testing under TSCA or FIFRA.
This part of the research will be conducted according to established
TSCA/FIFRA procedures and guidelines.
B. Private-Sector Voluntarism
As part of the SSARP, on February 7, 1992, ATSDR announced a set of
proposed procedures for conducting voluntary research (57 FR 4758).
Revisions based on public comments were published on November 16, 1992
(57 FR 54160). ATSDR strongly encourages private-sector organizations
to propose research to address data needs at any time until ATSDR
announces that research has already been initiated for a specific data
need. Private-sector organizations may volunteer to conduct research to
address specific priority data needs identified in this Notice by
indicating their interest through submission of a letter of intent.
[[Page 42661]]
The letter of intent should be a brief statement (1-2 pages) that
identifies the priority data need(s) to be filled, and the methods to
be used. The Tri-Agency Superfund Applied Research Committee (TASARC)
will review these proposals and make recommendations to ATSDR regarding
which specific voluntary research projects should be pursued and how
they should be conducted with the volunteer organizations. ATSDR will
enter into only those voluntary research projects that lead to high
quality, peer-reviewed scientific work. Additional details regarding
the process for voluntary research are in the Federal Register notices
cited in this section.
C. CERCLA
Those priority data needs that are not addressed by TSCA/FIFRA or
initial voluntarism will be considered for funding by ATSDR through its
CERCLA budget. A large part of this research program is envisioned to
be unique to CERCLA, for example, research on substances not regulated
by other programs or research needs specific to public health
assessments. Current examples of the direct use of CERCLA funds include
interagency agreements with other federal agencies and cooperative
agreements and grants with academic institutions.
Mechanisms to address these priority data needs may include a
second call for voluntarism. Again, scientific peer review of study
protocols and results would occur for all research conducted under this
auspice.
Substance-Specific Priority Data Needs
The priority data needs are identified in Table 1. Unique
identification numbers (37A through 46G) are assigned to the priority
data needs for this list of 10 priority hazardous substances; the
initial list of 38 substances has identification numbers 1A through 24C
(64 FR 2760), and the second list of 12 substances has identification
numbers 25A through 36G (64 FR 2760).
As previously stated, segments of the proposed research are unique
to CERCLA and may be most appropriately addressed by ATSDR programs as
follows.
ATSDR's responsibility as a public health agency addressing
environmental health issues is, when appropriate, to collect human data
to validate substance-specific exposure and toxicity assumptions. ATSDR
will obtain this information by conducting exposure and health effects
studies, and by establishing and using substance-specific subregistries
of people enrolled in the agency's National Exposure Registry who are
potentially exposed to these substances. When a subregistry or a human
exposure study is identified as a priority data need, the responsible
ATSDR program will determine its feasibility, which depends on
identifying appropriate populations and funding.
In addition, the need to collect, evaluate, and interpret
environmental data from contaminated media around hazardous waste sites
remains a priority data need for all 10 priority hazardous substances
ATSDR has identified for this third set. However, some of this
information has already been collected through individual state
programs and the EPA's CERCLA activities; therefore, ATSDR will
evaluate the extant information from these programs to better
characterize the need for additional site-specific information.
ATSDR acknowledges that the conduct of human studies to determine
possible links between exposure to hazardous substances and human
health effects may be accomplished through mechanisms other than agency
programs. We encourage private-sector organizations and other
governmental programs to use ATSDR's priority data needs to plan their
research activities, including identifying appropriate populations and
conducting studies to answer specific human health questions.
Table 1.--Substance-Specific Priority Data Needs (PDN) for Third Set of 10 Priority Hazardous Substances
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Substance PDN ID Priority data needs
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Asbestos................................. 37A 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.
37B Immunotoxicity studies of individuals
occupationally exposed to asbestos.
37C Development of human and rat lung
retention models to aid in extrapolating
between rat and human data.
37D 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.
37E 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.
37F 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.
37G Potential candidate for subregistry of
exposed persons.
Benzidine................................ 38A Dose-response data for acute-and
intermediate-duration exposure via the
oral route (the study of subchronic-
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).
38B Exposure levels in humans living near
hazardous waste sites.
38C Exposure levels of children.
38D Potential candidate for subregistry of
exposed persons.
Chlorinated dibenzo-p-dioxins............ 39A Studies via oral exposure designed to
assess childhood susceptibility.
39B Comparative toxicokinetic studies
examining the relative absorption of CDDs
across exposure routes and the relative
contribution of each exposure route to
total body burdens.
39C Exposure levels in humans living near
hazardous waste sites.
39D Exposure levels of children.
[[Page 42662]]
1,2-Dibromoethane........................ 40A Dose-response data in animals for acute-
and intermediate-duration exposure by the
oral route (the study of intermediate-
duration exposure should include
neuropathology and observation for overt
signs of neurotoxicity).
40B Multigeneration reproductive toxicity
studies via oral exposure.
40C Developmental toxicity studies via oral
exposure.
40D Immunotoxicity battery studies via oral
exposure.
40E Exposure levels in humans living near
hazardous waste sites and in other
populations such as workers exposed to
1,2-dibromoethane.
40F Exposure levels of children.
40G Potential candidate for subregistry of
exposed persons.
1,2-Dichloroethane....................... 41A Dose-response data in animals for acute-
duration (14-day) exposure by the
inhalation route, including a comparison
of young and adult animals.
41B Dose-response data in animals for acute-
duration (14-day) exposure by the oral
route, including a comparison of young
and adult animals.
41C 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).
41D Neurotoxicology battery of tests following
inhalation exposure.
41E Neurotoxicology battery of tests following
oral exposure.
41F Dose-response data in animals for chronic-
duration exposure by the oral route.
41G Developmental toxicity data for inhalation
exposure (assessment of developmental
cardiotoxicity and neurotoxicity).
41H Developmental toxicity data for oral
exposure (assessment of developmental
cardiotoxicity and neurotoxicity).
41I Additional analyses and studies for
comparative toxicokinetics across
species, ages, routes, and durations.
41J Children's susceptibility.
41K Exposure levels in humans living near
hazardous waste sites.
41L Exposure levels of children.
41M Potential candidate for subregistry of
exposed persons.
1,1-Dichloroethene....................... 42A Dose-response data in animals for acute-
duration exposure by the inhalation
route.
42B Dose-response data in animals for chronic-
duration exposure by the inhalation
route.
42C Dose-response data in animals for acute-
and intermediate-duration exposure by the
oral route.
42D Carcinogenicity studies in two species
following inhalation exposure.
42E Reproductive toxicity studies assessing
male and female end points following
inhalation exposure.
42F Developmental toxicity studies following
oral exposure.
42G Immunotoxicology battery of tests
following oral exposure.
42H Battery of neurobehavioral tests following
inhalation exposure.
42I Children's susceptibility.
42J Exposure levels in humans living near
hazardous waste sites.
42K Exposure levels of children.
42L Potential candidate for subregistry of
exposed persons.
Ethylbenzene............................. 43A Dose-response data for acute-duration
exposure by the inhalation route.
43B Dose-response data for chronic-duration
exposure by the inhalation route.
43C 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.
43D Multigeneration toxicity study examining
reproductive end points and indicators of
endocrine disruption following inhalation
exposure.
43E Two-species developmental study with
continued assessment of offspring during
postnatal development following oral
exposure.
43F Studies for comparative toxicokinetics.
43G Exposure levels in humans living near
hazardous waste sites.
43H Exposure levels in children.
43I Potential candidate for subregistry of
exposed persons.
Pentachlorophenol........................ 44A In vivo endocrine disruptor studies via
oral exposure.
44B Multigeneration reproduction study
involving multiple matings and examining
male and female fertility via oral
exposure.
44C Comparative toxicokinetic studies.
44D Exposure levels in humans living near
hazardous waste sites.
44E Exposure levels of children through play
activities near contaminated
environmental media.
44F Potential candidate for subregistry of
exposed persons.
1,1,2,2-Tetrachloroethane................ 45A Two-species developmental toxicity study
by the oral route.
45B Immunotoxicity battery following oral
exposure.
45C Mammalian in vivo genotoxicity assays.
45D Exposure levels in humans living near
hazardous waste sites.
45E Exposure levels of children.
45F Potential candidate for subregistry of
exposed persons.
Total xylenes............................ 46A Dose-response data for chronic-duration
exposure by the oral route. This study
should be done in conjunction with the
neurotoxicology battery of tests.
46B Neurotoxicology battery of tests following
oral exposure.
[[Page 42663]]
46C Two-generation reproductive study
following oral exposure.
46D Developmental toxicity study that includes
neurodevelopmental end points following
oral exposure.
46E Exposure levels in humans living near
hazardous waste sites.
46F Exposure levels of children.
46G Potential candidate for subregistry of
exposed persons.
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Dated: August 7, 2001.
Georgi Jones,
Director, Office of Policy and External Affairs, Agency for Toxic
Substances and Disease Registry.
[FR Doc. 01-20373 Filed 8-13-01; 8:45 am]
BILLING CODE 4163-70-P