[Federal Register Volume 62, Number 146 (Wednesday, July 30, 1997)]
[Notices]
[Pages 40820-40828]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-20012]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Toxic Substances and Disease Registry
[ATSDR-124]
Announcement of Final Priority Data Needs for 12 Priority
Hazardous Substances and Call for Voluntary Research Proposals
AGENCY: Agency for Toxic Substances and Disease Registry (ATSDR), U.S.
Department of Health and Human Services (HHS).
ACTION: Announcement of final priority data needs and ongoing call for
Voluntary Research Proposals.
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SUMMARY: This notice announces the final priority data needs for 12
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, 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 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 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 were initially
announced by ATSDR in the Federal Register on April 1, 1996 (61 FR
14430). The public was invited to comment on the priority data needs
during a 90-day period. ATSDR received comments from industry groups
concerning substance-specific priority data needs. The agency responded
to these comments and has finalized the ``Priority Data Needs''
documents for these 12 hazardous substances. Both the agency's
responses and the revised ``Priority Data Needs'' documents are
available for public inspection at ATSDR (see ADDRESSES section).
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). 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
``Priority Data Needs'' documents are available by writing to ATSDR
(see ADDRESSES section).
DATES: ATSDR considers the voluntary research effort to be of
significant importance 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 research has been initiated for a
specific data need.
ADDRESSES: Private-sector organizations interested in volunteering to
conduct research to address identified data needs should announce their
intention by writing to Dr. William Cibulas, Research Implementation
Branch, Division of Toxicology, Agency for Toxic Substances and Disease
Registry, 1600 Clifton Road, NE., Mailstop E-29, Atlanta, Georgia
30333. Requests for the final ``Priority Data Needs'' documents and
ATSDR's response to public comments should be addressed similarly.
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These documents are available for public inspection at the Agency
for Toxic Substances and Disease Registry, Building 4, Suite 2400,
Executive Park Drive, Atlanta, Georgia (not a mailing address), from 8
a.m. until 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, Agency for Toxic Substances and Disease Registry, 1600
Clifton Road, NE., 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-Specified 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).
Twelve substances constitute the second list of hazardous
substances for which priority data needs are identified by ATSDR. The
priority data needs for these 12 substances were initially announced by
ATSDR in the Federal Register on April 1, 1996 (61 FR 14430). 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 ATSDR, 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, ARSDR
considers the recommendations of the Interagency Testing Committee
(ITC) established under Section 4(e) of TSCA. Federally funded projects
that collection 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.
Implementation of Substance-Specified 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 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.
CERCLA also requires that ATSDR consider recommendations of the ITC
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 April 1, 1996 (61 FR 14420).
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.
Currently, in collaboration with EPA, the ATSDR test rule for seven
organic chemicals (benzene, trichloroethylyene, tetrachloroethylene,
cyanide, toluene, methylene chloride, and chloroethane) is being
developed. In addition, the Metals Testing Task Force, consisting of
scientists from ATSDR, EPA, and NIEHS, met last February and
established a draft list of priority metals (including all of ATSDR's
priority metals) for testing. A draft survey for soliciting testing
needs of other government agencies was also developed. A second meeting
of the Task Force to help set priorities for testing needs is scheduled
for early fall.
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
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(e.g., via EPA test rule development). 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
identifies the priority data need(s) to be addressed 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 only enter into 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.
Recently, the first research study conducted under ATSDR's
voluntary research program was completed. The study, conducted by the
Halogenated Solvents Industry Alliance, Inc. (HSIA), addressed three
priority data needs for methylene chloride using physiologicially-based
parhmacokinetic (PBPK) modeling. HSIA has also proposed to conduct an
immunotoxicity assessment for methylene chloride via inhalation
exposure, and to obtain the oral immunotoxicity data via PBPK modeling.
HSIA and ATSDR are continuing to discuss voluntary research efforts for
trichloroethylene and tetrachloroethylene.
Presently, ATSDR has three memorandums of understanding with
private-sector organizations: HSIA, to conduct studies on methylene
chloride; the Chemical Manufacturers Association, to conduct research
on vinyl chloride; and the General Electric Company (GE), to conduct
studies on polychlorinated biphenyl compounds. The final report of GE's
study on an assessment of the chronic toxicity and oncogenicity of
Aroclor-1016, Aroclor-1242, Aroclor-1254, and Aroclor-1260 administered
in diet to rats was recently reviewed by ATSDR's peer reviewers. ATSDR
will accept the report pending GE's satisfactory response to the
review's comments.
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 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 final 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
environmental media around hazardous waste sites. However, a
substantial amount of this information has already been collected
through individual State programs and EPA's CERCLA activities. ATSDR
scientists will, therefore, evaluate the extant information from these
programs 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 ATSDR's 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.
The results of the research conducted via this ATSDR Substance-
Specific Applied Research Program will be used for public health
assessment purposes and to reassess ATSDR's substance-specific priority
data needs. ATSDR intends to reevaluate the priority data needs for
hazardous substances every three years.
Dated: July 24, 1997.
Georgi Jones,
Director, Office of Policy and External Affairs, Agency for Toxic
Substances and Disease Registry.
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[FR Doc. 97-20012 Filed 7-29-97; 8:45 am]
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