[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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