[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





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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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