[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.

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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.

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                                           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