[Federal Register Volume 60, Number 27 (Thursday, February 9, 1995)]
[Notices]
[Pages 7766-7770]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-3292]



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ENVIRONMENTAL PROTECTION AGENCY
[FRL-5150-8]


Office of Research and Development Office of Exploratory 
Research; Reducing Uncertainty in Risk Assessment and Improving Risk 
Reduction Approaches

AGENCY: Environmental Protection Agency.

ACTION: 1995 Grants for Research.

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SUMMARY: The U.S. Environmental Protection Agency (EPA) invites 
research grant applications in four areas of special interest to its 
mission:
    <bullet> Human health risk assessment.
    <bullet> Indoor air quality in large office buildings.
    <bullet> Air pollutants (particulate matter, tropospheric ozone, 
and toxics).
    <bullet> Regional hydrologic vulnerability to global climate 
change.
    This invitation provides relevant background information, 
summarizes EPA interests in the four topic areas, and describes the 
application and review process.

Background

    EPA has increased funding for its investigator-initiated research 
grants in fiscal year 1995. EPA therefore is issuing two additional 
Requests for Applications (RFAs), of which this is one. The other is a 
joint solicitation with the National Science Foundation (NSF) that 
identifies three areas of interest to both agencies--water and 
watersheds; valuation and environmental policy; and technology for a 
sustainable environment (pollution prevention).
    Information on the NSF/EPA solicitation can be obtained by 
contacting Dr. Penny Firth at NSF, (703) 306-1480, or Dr. Melinda 
McClanahan at EPA, (202) 260-7473.

EPA Mission and R&D Strategy

    The mission of EPA--and its unique role--is the joint protection of 
environmental quality and human health through effective regulations 
and other policy decisions. Achievement of this mission requires the 
application of sound science to the assessment of environmental 
problems and evaluation of solutions. Moreover, a significant challenge 
is to support long-term research that anticipates future environmental 
problems and strives to fill significant gaps in knowledge relevant to 
meeting regulatory goals.
    This Request for Applications and the joint EPA/NSF solicitation 
are important steps toward ensuring that EPA is positioned to provide 
national leadership as the country enters a new generation of 
environmental protection.
    EPA recently reorganized its research programs to focus on major 
areas of uncertainty associated with assessment and reduction of risks 
to human health and ecosystems. Through its laboratories and through 
grants to universities and other not-for-profit institutions, EPA will 
conduct and support research in the subject matter areas where 
regulatory officials face the most significant gaps in knowledge about 
environmental risks. Because risk is a function of both hazard and 
exposure, EPA will promote research in both domains--according highest 
[[Page 7767]] priority to those areas where risk assessors are most in 
need of new concepts, data, and methods. At the same time, EPA will 
foster the development and evaluation of new risk reduction 
technologies across a spectrum, from pollution prevention through end-
of-pipe controls, to remediation and monitoring.

Research Topics of Interest

1. Human Health Risk Assessment

    As described in the recent NRC report entitled ``Science and 
Judgement in Risk Assessment,'' EPA uses health risk assessments to 
establish exposure limits and set priorities for regulatory activities. 
However, EPA is hampered by gaps in methods, models, and data needed to 
support risk assessments. In many cases default assumptions are used to 
extrapolate from animals to humans, from high to low doses, from acute 
to chronic exposures, and from lowest effect levels to no-effect 
levels.
    One of EPA's Office of Research and Development's major research 
goals is to reduce reliance on such assumptions. For example, EPA needs 
biologically and physiologically-based predictive models that will 
provide new concepts, data, and methods that can replace default 
assumptions.
    Research is needed on the following areas.
    <bullet> Methods for estimating dose from cumulative human exposure 
(e.g., via air, water, soil, and food) to significant and persistent 
environmental contaminants. This research is intended to support 
evaluation of cumulative exposure and dose apportionment and to 
demonstrate the application of the methods developed to estimate human 
health risks.
    <bullet> Principles governing age-dependent responses to 
environmental contaminants and to improve capabilities for animal-to-
human extrapolation of health risks. Neurotoxicity is a priority 
response to be evaluated, but other end points will be considered.
    <bullet> Quantitative toxicokinetic and toxicodynamic interactions 
among chemicals in environmental mixtures of members of chemical 
classes that are significant environmental contaminants (e.g., PAHs, 
halogenated solvents, metals, chlorinated dioxins and furans, PCBs, and 
pesticides).
    <bullet> Toxicological interactions such as additivity, synergism, 
and antagonism in such mixtures. To improve the ability to estimate 
risks from environmental exposures, a priority is research that is 
focused on realistic exposures to environmental contaminants.
    <bullet> Methods for quantifying non-cancer risks, such as 
reproductive or developmental disorders. Of special interest are 
methods that are based on validated correlations between biochemical or 
physiological markers and clinical end-points.
    <bullet> Inter-individual and intra-individual variability in 
factors that affect susceptibility to toxicity from environmental 
contaminants. Further, research is needed to elucidate relationships 
between such variability and disease outcome.
    <bullet> Human and animal reproductive processes vulnerable to 
environmental contamination. This research is needed to identify 
keystone or sentinel species whose reproduction can be monitored to 
signal potential risk to other species, including humans.
    <bullet> Major uncertainties in risk assessment for microbial 
pathogens in surface and drinking waters. For example, critical gaps in 
knowledge exist with respect to occurrence and levels of microbial 
waterborne pathogens, infectious dose, survival in the environment, and 
susceptibility to treatment processes.
    <bullet> Other research areas as defined by proposers that 
contribute to the overall goals of this research topic.
    Approximately $3.0 million will be available from fiscal year 1995 
funds. A typical project will be supported for a period of up to 3 
years at $150,000 per year.

2. Indoor Air Quality in Large Office Buildings

    The 1986 Superfund Amendments and Reauthorization Act (SARA) Title 
IV directs EPA to conduct and support research on indoor air quality. 
An important aspect of this research is improving the scientific 
understanding of, and reducing the uncertainties surrounding, the 
relationships among indoor air quality, human exposures, and large 
building design and operation.
    Of interest are cross-sectional and/or longitudinal studies of 
large office buildings in relatively large geographical regions across 
the United States that characterize the relationships among:
    <bullet> The physical, mechanical and environmental factors that 
influence indoor air quality;
    <bullet> Relevant human exposures to aerosols, micro-organisms, 
volatile organic compounds, and other parameters such as air exchange 
rate and pesticides;
    <bullet> The pathways through which these exposures occur;
    <bullet> Occupant perceptions of indoor air quality and occupant 
productivity;
    <bullet> The extent to which human activity patterns, building 
system operating practices or design, and indoor or outdoor air quality 
affect these exposures; and
    <bullet> Other research areas as defined by proposers that 
contribute to the overall goals of this research topic.
    To provide high quality data necessary for intra- and inter-
building comparisons, minimum data requirements and analytical 
protocols must be the same or equivalent to those recommended in the 
following two documents: ``A Standardized EPA Protocol for 
Characterizing Indoor Air Quality in Large Office Buildings,'' (6/1/94) 
and ``The United States Environmental Protection Agency's Large 
Building Studies Quality Assurance Overview Document,'' (11/1/94). 
Copies of these two documents can be obtained by contacting Ross 
Highsmith at (919) 541-3121, or <a href="/cdn-cgi/l/email-protection#1363727b7f3d77727f76537663727e727a7f3d7663723d747c65"><span class="__cf_email__" data-cfemail="8efeefe6e2a0eaefe2ebceebfeefe3efe7e2a0ebfeefa0e9e1f8">[email protected]</span></a>.
    Approximately $1.5 million will be available from fiscal year 1995 
funds. A typical project will be supported for a period of up to 3 
years at $150,000 per year.

3. Air Pollutants (Particulate Matter, Tropospheric Ozone, and Toxics)

    Certain widespread (criteria) air pollutants, such as ozone and 
particulate matter (PM), continue to pose serious public health risks 
for susceptible members of the U.S. population or risks to sensitive 
ecosystems. The Clean Air Act requires that EPA establish and 
periodically review and revise, as appropriate, criteria and National 
Ambient Air Quality Standards (NAAQS) for such pollutants. The Act also 
requires State Implementation Plans (SIPs) to be prepared, which 
describe control strategies that States and local authorities will 
employ to bring non-attainment areas into compliance with the NAAQS.
    The EPA is seeking investigator-initiated grant proposals aimed at 
generating new knowledge to:
    (1) Improve the scientific basis for future reassessment of the PM 
NAAQS;
    (2) Reduce uncertainties in SIP modeling projections for 
tropospheric ozone and measurement of the effectiveness of SIPs in 
meeting the ozone NAAQS;
    (3) Increase the understanding of transport and deposition of 
volatile and semi-volatile toxic pollutants, and the ultimate exposure 
of humans and ecosystems to them; and
    (4) Other research areas as defined by proposers that contribute to 
the overall goals of this research topic. [[Page 7768]] 
    Of particular interest in relation to the first area are projects 
that will provide information useful in resolving controversies 
regarding epidemiologic analyses that suggest associations between 
increased mortality and morbidity, and particulate matter 
concentrations markedly below the current particulate matter NAAQS, 
including:
    <bullet> Improving quantitative estimates of particulate matter 
exposure;
    <bullet> Employment of epidemiologic analyses that more directly 
estimate potential effects; and
    <bullet> Evaluation of potential confounding variables (e.g., 
weather).
    Possible approaches may involve, but are not restricted to, 
alternative biostatistical models, coupling existing or refined 
epidemiologic analyses to improved exposure data, case-control or 
cross-sectional studies of mortality, indices of morbidity, and/or 
biomarkers of effects. The relative roles of fine versus coarse 
particles and of chemical composition are of particular interest.
    Of interest in the second area is fundamental research in the 
atmospheric chemistry, modeling, emissions, and ambient measurement of 
tropospheric ozone contributing to strengthened control strategy 
development and improved assessment of SIP effectiveness, including:
    <bullet> Kinetic and mechanistic studies of gas-phase reactions 
involving aromatic volatile organic compounds (VOCs), biogenic VOCs, 
long-chain alkenes and alkanes that participate in ambient 
photochemistry, and studies on the link between ozone and heterogeneous 
or aqueous-phase reactions;
    <bullet> Studies to explore boundary layer turbulence and mixing, 
and their interaction with atmospheric chemistry, and studies of 
quantitative techniques for assessing the errors or uncertainties 
inherent in concentration estimates from ozone air quality modeling 
systems;
    <bullet> Studies of large-scale fluxes of biogenic emissions of 
VOCs and NO<INF>X for different landscapes;
    <bullet> Studies that may lead to new techniques for ambient 
measurement, on short time scales, of chemically-significant trace 
gases participating in the photochemistry of ozone; and
    <bullet> Both in-situ and remotely-sensed studies of innovative 
methods for using ambient concentration and meteorological measurements 
in assessing the potential ozone response to local changes in precursor 
emissions/concentrations.
    Of interest in the third area are projects that address compounds, 
including aerosols, semi-volatile pollutants, and/or trace metals that 
travel through the air pathway, especially those that are persistent, 
mobile, or bioaccumulative. Also of interest are projects that 
investigate major uncertainties in:
    <bullet> Transport and atmospheric phase equilibria;
    <bullet> Composition versus particle size;
    <bullet> Deposition to surfaces;
    <bullet> Food chain uptake from atmospheric deposition; and/or
    <bullet> Dermal exposure from atmospheric deposition.
    Projects are encouraged that result in new or improved databases, 
algorithms, models, or modules for pre-existing models that can be used 
by the scientific community in the analysis of transport and fate of 
air toxics; the quantification of air and air-deposition pathways; and 
the assessment of risks for air toxics.
    Approximately $2.5 million will be available from fiscal year 1995 
funds. A typical project will be supported for a period of up to 3 
years at $150,000 per year.

4. Regional Hydrologic Vulnerability to Global Climate Change

    Vulnerability research is a major responsibility of EPA's Global 
Climate Change Research Program. Understanding regional vulnerability 
to climate change is critically dependent on understanding how 
projected wide-spread climate change affects the hydrologic watershed 
at scales where water resources and related ecologic, economic, and 
socio-political impacts are manifested. In order to make informed 
decisions concerning the risks of global change, the public and 
policymakers need a better understanding of the hydrologic 
vulnerabilities of regional systems. This, in turn, requires improved 
methodologies that identify and quantify physical and economic regional 
vulnerabilities to competing hydrologic demands, under current climate 
patterns and under projected climate-change scenarios.
    Attempts to quantify these types of vulnerabilities have been 
hampered by the absence of techniques for performing regional analyses 
using projected climate change. These regional analyses should include 
both direct hydrologic response (e.g., soil moisture, streamflow, 
stream temperature) as well as secondary impacts upon regional ecology 
and economics. Major sources of uncertainty in conducting regional 
hydrologic analyses are the sensitivities of regional hydrologic 
systems to changing climate and future demands for water. Accordingly, 
as part of EPA's interest in watershed research, this solicitation 
invites proposals that address climate change aspects of watershed 
hydrology in the following areas:
    <bullet> Translation of climatic information into water 
availability (e.g., soil moisture and streamflow) and other ecologic 
variables as required by water resource and natural resource modelers.
    <bullet> Linkage of water availability with water and natural 
resource response prediction.
    <bullet> Linkage with economic activities in various sectors (e.g., 
agriculture and forestry) competing for the water resources, and 
associated feedbacks.
    <bullet> Other research areas as defined by proposers that 
contribute to the overall goals of this research topic.
    This solicitation seeks proposals that may include a range of 
innovative research approaches, from modeling to data analysis and 
observational and experimental approaches, singly or in combination. 
Proposals are encouraged without regard to specific location of any 
proposed hydrologic regional setting but should reflect the goal to 
reduce uncertainties in watershed hydrology as influenced by concerns 
about vulnerabilities to climate change.
    Approximately $1.0 million will be available from fiscal year 1995 
funds. A typical project will be supported for a period of up to 3 
years at $150,000 per year.

The Application

    Proposed projects must be research designed to advance the state of 
knowledge in the indicated areas of environmental science and 
technology. Applications will not be accepted for routine monitoring, 
state-of-the-art or market surveys, literature reviews, development or 
commercialization of proven concepts, or for the preparation of 
materials and documents, including process designs or instruction 
manuals.
    Application forms and instructions are available in the EPA 
Research Grants Application Kit. Interested investigators should review 
the materials in this kit before preparing an application for 
assistance. The kits can be obtained at the following address: U.S. 
Environmental Protection Agency, Office of Research and Development, 
Office of Exploratory Research (8703), 401 M Street SW., Washington, DC 
20460, (202) 260-7474.
    Each application for assistance must consist of the Application for 
Federal Assistance Forms (Standard Forms--SF 424 and 424A), separate 
sheets that provide the budget breakdown for each year of the project, 
the resumes for the principal investigator and co-workers, the abstract 
of the proposed project, and [[Page 7769]] a project narrative that 
includes a quality assurance narrative. All certification forms (e.g., 
lobbying certification) must be signed and included with the 
application.
    The closing date for application submission is April 17, 1995 at 
4:00 p.m. est.
    To be considered, the original and eight copies of the fully 
developed research grant application, prepared in accordance with 
instructions in the Application for Federal Assistance Forms, must be 
received by the EPA Office of Exploratory Research no later than the 
above closing date. Informal, incomplete, or unsigned proposals will 
not be considered. Completed applications should be sent via regular or 
express mail to: U.S. Environmental Protection Agency, Office of 
Research and Development, Office of Exploratory Research (8703), 401 M 
Street SW., Washington, DC 20460.
    Applications sent via express mail should have the following 
telephone number listed on the express mail label: (202) 260-7445.

Special Instructions

    The following special instructions apply to all applicants 
responding to this Request for Application.
    <bullet> Applications must be unbound and clipped or stapled. The 
SF-424 must be the first page of the application. Budget information 
should immediately follow the SF-424. All certification forms should be 
placed at the end of the application.
    <bullet> Applicants must be identified by printing ``OER-95'' in 
block 10 of the SF-424. This will facilitate proper assignment and 
review of the application.
    <bullet> A one-page abstract must be included with the application.
    <bullet> The ``project narrative'' section of the application must 
not exceed 25, consecutively-numbered, 8\1/2\  x  11 inch pages of 
standard type (i.e., 12 point), including tables, graphs, and figures. 
For purposes of this limitation, the ``project narrative'' section of 
the application consists of the following six items:

1. Description of Project
2. Objectives
3. Results or Benefits Expected
4. Approach
5. General Project Information
6. Quality Assurance

    Any attachments, appendices, and other references for the narrative 
section may be included but must remain within the 25-page limitation. 
Appendices will not be considered an integral part of the narrative.
    Items not included under the 25-page limitation are the SF-424 and 
other forms, budgets, resumes, and the abstract. Resumes must not 
exceed two consecutively-numbered pages for each investigator and 
should focus on education, positions held, and most recent or related 
publications.
    Applications not meeting these requirements will be returned to the 
applicant without review.

Quality Assurance

    Data sets resulting from EPA-funded environmental research often 
are used directly by regulatory officials when establishing standards 
or when making other policy decisions. Explicit indicators of data 
quality are essential for determining whether a particular data set is 
appropriate for use in a specific context. To that end, EPA regulations 
require that grant-funded projects address quality assurance.
    The application must include a quality assurance narrative 
statement, not to exceed two pages, which for each item listed below, 
either presents the required information or provides justification as 
to why the item does not apply to the proposed research.
    <bullet> The intended use of the data and the associated acceptance 
criteria for data quality (i.e., precision, accuracy, 
representativeness, completeness, and comparability).
    <bullet> Project requirements for precision, accuracy, 
representativeness, completeness, and comparability, and how these will 
be determined.
    <bullet> Procedures for selection of samples or sampling sites, and 
collection or preparation of samples.
    <bullet> Procedures for sample handling, identification, 
preservation, transportation, and storage.
    <bullet> Description of measurement methods or test procedures, 
with a statement of performance characteristics if methods are non-
standard.
    <bullet> Standard quality assurance/quality control procedures 
(e.g., American Society for Testing Materials, American Public Health 
Association, etc.) to be followed. Non-standard procedures must be 
documented.
    <bullet> Data reduction and reporting procedures, including 
description of statistical analyses to be used.

Guidelines and Limitations

    All recipients are required to provide a minimum of 1% of the total 
project cost, which may not be taken from Federal sources. Subcontracts 
for research to be conducted under the grant should not exceed 40% of 
the total direct cost of the grant for each year in which the 
subcontract is awarded.

Eligibility

    Academic and not-for-profit institutions located in the U.S., and 
state or local governments are eligible under all existing 
authorizations. Profit-making firms are eligible only under certain 
laws, and then under restrictive conditions, including the absence of 
any profit from the project. Federal agencies and federal employees are 
not eligible to participate in this program. Potential applicants who 
are uncertain of their eligibility should contact EPA's Grants 
Operations Branch at (202) 260-9266.

Review and Selection

    All grant applications are initially reviewed by EPA to determine 
their legal and administrative acceptability and responsiveness to this 
solicitation. Acceptable applications are then reviewed by an 
appropriate technical peer review group. This review is designed to 
evaluate and rank each proposal according to its scientific merit. Each 
review group is composed primarily of non-EPA scientists, engineers, 
social scientists, and/or economists who are experts in their 
respective disciplines. All reviewers are proficient in the technical 
areas that they are reviewing. The reviewers use the following criteria 
in their reviews:
    <bullet> Quality of the research plan (including theoretical and/or 
experimental design, originality, and creativity);
    <bullet> Qualifications of the principal investigator and staff, 
including knowledge of relevant subject areas;
    <bullet> Potential contribution of the research to advancing 
scientific knowledge in the environmental area;
    <bullet> Availability and adequacy of facilities and equipment; and
    <bullet> Budget justification--justification for equipment will 
receive special attention.
    A summary statement of the scientific review of the panel is 
provided to each applicant.
    Funding decisions are the sole responsibility of EPA. Grants are 
selected on the basis of technical merit, relevancy to the research 
priorities outlined, program balance, and budget.

Proprietary Information

    By submitting an application in response to this solicitation, the 
applicant grants EPA permission to share the application with technical 
reviewers both within and outside of the Agency.
    Applications containing proprietary or other types of confidential 
information will be immediately returned to the applicant without 
review. [[Page 7770]] 

Funding Mechanism

    The funding mechanism for all awards issued under this solicitation 
will consist of a grant agreement between EPA and the recipient.
    In accordance with Public Law 95-224, a grant is used to accomplish 
a public purpose of support or stimulation authorized by Federal 
statute rather than acquisition for the direct benefit of the Agency. 
In using a grant instrument rather than a cooperative agreement, EPA 
anticipates that there will be no substantial involvement during the 
course of the grant, between the recipient and the Agency.

Minority Institution Assistance

    Pre-application assistance is available upon request for potential 
investigators representing institutions identified by the Secretary, 
Department of Education, as Historically Black Colleges or Universities 
(HBCUs), Hispanic Association of Colleges and Universities (HACUs), or 
Native American or Tribal Colleges. For further information on minority 
assistance, contact Charles Mitchell by telephone at (202) 260-7473, by 
faxing a written request to (202) 260-0211, or by mailing it to the 
above-listed address for EPA's Office of Exploratory Research.

Contacts

    Additional general information on the grants program may be 
obtained by contacting: U.S. Environmental Protection Agency, Office of 
Exploratory Research (8703), 401 M Street SW., Washington, DC 20460, 
Phone: (202) 260-7474, Fax: (202) 260-0211.
    Applicants with technical questions may contact the appropriate 
individual identified below.

Contacts for Research Topics of Interest

Human Health Risk Assessment
    <bullet> Kevin Garrahan (202) 260-2588.
Indoor Air Quality in Large Office Buildings
    <bullet> Ross V. Highsmith (919) 541-7828.
    <bullet> Kevin Y. Teichman (202) 260-7669.
Air Pollutants (particulates, ozone, & toxics)
    <bullet> Ila L. Cote (919) 541-3644 (particulates).
    <bullet> James S. Vickery (919) 541-2184 (ozone).
    <bullet> Larry T. Cupitt (919) 541-2454 (toxics).
Regional Hydrologic Vulnerability to Global Climate Change
    <bullet> Barbara M. Levinson, (202) 260-5983.
    <bullet> Joel D. Scheraga, (202) 260-4029.

    Dated: February 1, 1995.

    Approved:
Robert J. Huggett,
Assistant Administrator for Research and Development.
[FR Doc. 95-3292 Filed 2-8-95; 8:45 am]
BILLING CODE 6560-50-P

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