[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:
Human health risk assessment.
Indoor air quality in large office buildings.
Air pollutants (particulate matter, tropospheric ozone,
and toxics).
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.
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.
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.
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).
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.
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.
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.
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.
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.
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:
The physical, mechanical and environmental factors that
influence indoor air quality;
Relevant human exposures to aerosols, micro-organisms,
volatile organic compounds, and other parameters such as air exchange
rate and pesticides;
The pathways through which these exposures occur;
Occupant perceptions of indoor air quality and occupant
productivity;
The extent to which human activity patterns, building
system operating practices or design, and indoor or outdoor air quality
affect these exposures; and
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 pahl.dale@epamail.epa.gov.
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:
Improving quantitative estimates of particulate matter
exposure;
Employment of epidemiologic analyses that more directly
estimate potential effects; and
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:
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;
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;
Studies of large-scale fluxes of biogenic emissions of
VOCs and NOX for different landscapes;
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
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:
Transport and atmospheric phase equilibria;
Composition versus particle size;
Deposition to surfaces;
Food chain uptake from atmospheric deposition; and/or
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:
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.
Linkage of water availability with water and natural
resource response prediction.
Linkage with economic activities in various sectors (e.g.,
agriculture and forestry) competing for the water resources, and
associated feedbacks.
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.
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.
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.
A one-page abstract must be included with the application.
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.
The intended use of the data and the associated acceptance
criteria for data quality (i.e., precision, accuracy,
representativeness, completeness, and comparability).
Project requirements for precision, accuracy,
representativeness, completeness, and comparability, and how these will
be determined.
Procedures for selection of samples or sampling sites, and
collection or preparation of samples.
Procedures for sample handling, identification,
preservation, transportation, and storage.
Description of measurement methods or test procedures,
with a statement of performance characteristics if methods are non-
standard.
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.
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:
Quality of the research plan (including theoretical and/or
experimental design, originality, and creativity);
Qualifications of the principal investigator and staff,
including knowledge of relevant subject areas;
Potential contribution of the research to advancing
scientific knowledge in the environmental area;
Availability and adequacy of facilities and equipment; and
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
Kevin Garrahan (202) 260-2588.
Indoor Air Quality in Large Office Buildings
Ross V. Highsmith (919) 541-7828.
Kevin Y. Teichman (202) 260-7669.
Air Pollutants (particulates, ozone, & toxics)
Ila L. Cote (919) 541-3644 (particulates).
James S. Vickery (919) 541-2184 (ozone).
Larry T. Cupitt (919) 541-2454 (toxics).
Regional Hydrologic Vulnerability to Global Climate Change
Barbara M. Levinson, (202) 260-5983.
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]
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