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

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 [email protected].

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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