[Federal Register Volume 61, Number 63 (Monday, April 1, 1996)]
[Notices]
[Pages 14430-14438]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-7851]
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_______________________________________________________________________
Part VIII
Department of Health and Human Services
_______________________________________________________________________
Agency For Toxic Substances and Disease Registry
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Identification of Priority Data Needs for 12 Priority Hazardous
Substances; Notice
Federal Register / Vol. 61, No. 63 / Monday, April 1, 1996 /
Notices
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Toxic Substances and Disease Registry
[ATSDR-105]
Identification of Priority Data Needs for 12 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 12 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 12 priority hazardous substances 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).
Twelve substances constitute the second list of hazardous
substances for which priority data needs are 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 writing to the ATSDR (see ADDRESSES section of
this Notice).
The exposure and toxicity priority data needs in this Notice have
been identified from information gaps via a ``Decision Guide'' that was
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 are funded by
cooperative agreement 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
involved in human health assessments involving these 12 substances (and
related ones) by providing additional scientific information for the
risk assessment process.
The 12 substances, which are included in the ATSDR Priority List of
Hazardous Substances established by ATSDR and EPA (59 FR 9486, February
28, 1994), 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
* toxaphene.
The priority data needs for these 12 substances are presented
below. 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 research proposal 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 writing to ATSDR
(see ADDRESSES section of this Notice).
DATES: Comments concerning this Notice must be received by July 1,
1996.
ADDRESSES: Include the docket control number ATSDR-42 with comments on
this Notice. Submit comments to Dr. William Cibulas, Chief, Research
Implementation Branch, Division of Toxicology, ATSDR, 1600 Clifton
Road, N.E., Mailstop E-29, Atlanta, Georgia 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.
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FOR FURTHER INFORMATION CONTACT: Dr. William Cibulas, Chief, Research
Implementation Branch, Division of Toxicology, ATSDR, 1600 Clifton
Road, N.E., Mailstop E-29, Atlanta, Georgia 30333, telephone 404-639-
6306.
SUPPLEMENTARY INFORMATION:
Background
The Comprehensive Environmental Response, Compensation, and
Liability Act of 1980 (Superfund) or CERCLA (42 U.S.C. 9604 (i)), 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 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).
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 information
gaps found 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). Briefly, this guide identified categories of exposure and
toxicity data needs necessary to assess the four basic steps to perform
public health assessments.
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The links between the release of a hazardous substance in the
environment and the impact on human health can only be fully determined
when the scientific underpinnings for these four basic steps are known.
In the absence of these data, the public health assessment process must
use certain assumptions. The relationships between these four steps and
priority data needs are as follows:
Exposure Assessment
To meet its statutory mandates, ATSDR must make reasonable
scientific assessments based on levels of contaminants found in the
environment around CERCLA sites. To accomplish this goal, a major
objective of this research program is to establish links between levels
of contaminants in the environment and levels in human tissues or
target organs that may cause an adverse health effect. This requires
(1) the development and validation of sensitive analytical methods for
measuring levels of contaminants in environmental media, (2)
information on background levels in the general environment, (3)
information on contaminant levels at or near hazardous waste sites, and
(4) knowledge of the contaminants' environmental fate.
Relating environmental contaminant levels to human tissue
concentrations requires (1) the development and validation of sensitive
analytical methods for contaminant detection in human tissues, (2)
bioavailability data, (3) information on background levels in
nonexposed populations, and (4) information on levels in tissues for
populations living at or near hazardous waste sites. Thus, a major
priority data need for this applied research program will be to
collect, evaluate, and interpret data from hazardous waste sites for
both environmental media and human tissues, when appropriate.
Hazard Identification/Dose Response Assessment
Toxicologic and pharmacokinetic testing of priority hazardous
substances is necessary to identify target organs and to establish
tissue dosimetry. This information is critical to complete the
association among levels of these substances in the environment, levels
in human tissues, and levels associated with adverse health effects.
Priority data needs generally arise when information is lacking that
identifies the most sensitive target organs (and doses associated with
these effects) following acute, intermediate, and chronic exposures to
each substance. These data are needed to establish dose-response
relationships, identify thresholds for these effects, and to determine
levels of significant exposure to the hazardous substances that are
associated with adverse health effects.
The identified health effect studies are conducted via the most
relevant exposure route(s) representative of conditions at hazardous
waste sites. ATSDR will consider using physiologically based
pharmacokinetic (PBPK) modeling to address data needs when models are
well developed and validated.
Once links have been established across exposure routes, levels in
the environment, and in specific human tissues associated with health
effects, it should be feasible to develop strategies to lessen these
effects. Mechanistic studies can elucidate the pathophysiology of the
health effects
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and should ultimately lead to the development of clinical methods to
mitigate any adverse health effects from exposure to people living
around hazardous waste sites.
ATSDR scientists believe it is important to collect quality human
data to validate the substance-specific exposure and toxicity findings
from animal studies and equivocal human studies. This information will
come from exposure and health effects studies and through the
establishment of subregistries within the framework of ATSDR's National
Exposure Registry.
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
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 12 substances are now
on the ITC priority testing list.
The mechanisms for implementing the SSARP are discussed below. The
status of the SSARP in addressing priority data needs of the first set
of 38 priority hazardous substances via these mechanisms was described
in a Federal Register Notice on March 10, 1994 (59 FR 11434). This will
be updated in an upcoming Federal Register Notice.
A. TSCA/FIFRA
In developing and implementing the SSARP, ATSDR and EPA established
procedures to identify priority data needs of mutual interest to
Federal programs. Generally, this begins before or during the
finalization of the priority data needs. 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. Generally, this testing will
fulfill more than one Federal program's need.
B. Private-Sector Voluntarism
As part of the SSARP, on February 7, 1992, ATSDR announced a set of
proposed procedures for conducting voluntary research (56 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 research proposal.
The research proposal should be a brief statement (1-2 pages) that
addresses the priority data need(s) to be filled, and the methods to be
used. The TASARC will review these proposals. Based on the review
committee's recommendations, ATSDR will determine which specific
voluntary research projects will be pursued (and how) 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 (25A through 36H) are assigned to the priority
data needs for this list of 12 priority hazardous substances; the
initial list of 38 substances has identification numbers 1A through 24C
(59 FR 11434, March 10, 1994).
As previously stated, ATSDR believes that part of this research
will be most appropriately conducted using CERCLA data and resources.
Toward this end, ATSDR has identified particular data needs that may be
implemented by ATSDR programs. These priority data needs fall into both
the exposure and toxicity data needs categories.
A major exposure priority data need for all 12 substances will be
to collect, evaluate, and interpret data from contaminated media around
hazardous waste sites. However, a substantial amount of this
information has already been collected through individual State
programs and the EPA's CERCLA activities. ATSDR scientists will,
therefore, evaluate the extant information from these programs in order
to better characterize the need for additional site-specific
information.
ATSDR's role as a public health agency addressing environmental
health is, when appropriate, to collect human data to validate
substance-specific exposure and toxicity findings. 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. These priority data needs may be
reclassified following considerations of feasibility. Any
reclassification will be published in the Federal Register.
ATSDR acknowledges that the conduct of human studies to determine
possible links between exposure to hazardous substances and human
health effects may be accomplished other than by agency programs or
under other ATSDR-sponsored projects. 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.
Dated: March 26, 1996.
Claire V. Broome,
Deputy Administrator, Agency for Toxic Substances and Disease Registry.
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[FR Doc. 96-7851 Filed 3-29-96; 8:45 am]
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