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U.S. Environmental Protection Agency
Office of Research and Development
National Center for Environmental Research
Science to Achieve Results (STAR) Program

CLOSED - FOR REFERENCES PURPOSES ONLY

Epidemiologic Research on Health Effects of Long-Term Exposure to Ambient Particulate Matter and Other Air Pollutants

Opening Date: August 28, 2001
Closing Date: January 18, 2002

Summary of Program Requirements
Introduction
Background
Specific Areas of Interest
Funding
Eligibility
Standard Instructions for Submitting an Application
Contacts

Get Standard STAR Forms and Instructions (http://www.epa.gov/ncer/rfa/forms/index.html)
View NCER Research Capsules (http://www.epa.gov/ncer/publications/topical/)
View research awarded under previous solicitations (http://cfpub.epa.gov/ncer_abstracts/index.cfm/fuseaction/research.search/rpt/abs/type/3)

SUMMARY OF PROGRAM REQUIREMENTS
GENERAL INFORMATION

Program Title:

Epidemiologic Research on Health Effects of Long-Term Exposure to Ambient Particulate Matter and Other Air Pollutants

Synopsis of Program

The U.S. Environmental Protection Agency (EPA), as part of its Science to Achieve Results (STAR) program, is seeking applications for epidemiologic research on health effects of long-term exposure to ambient particulate matter and other air pollutants. Particulate matter has been linked to serious respiratory and cardiovascular diseases. The key effects associated with exposure to ambient particulate matter include: premature mortality, aggravation of respiratory and heart diseases (as indicated by increased hospital admissions and emergency room visits, school absences, work loss days, and restricted activity days), aggravated asthma, acute respiratory symptoms, chronic bronchitis, decreased lung function, and increased risk of myocardial infarction. This RFA invites applications for the following two specific types of particulate matter air pollution research: (1) retrospective epidemiologic studies that make use of currently available information on health and air quality; (2) methods/model development studies relating to future, prospective epidemiologic research.


Contact Person(s):
Stacey Katz; Phone: 202-564-8201; email: katz.stacey@epa.gov
Gail Robarge; Phone: 202-564-8301; email: robarge.gail@epa.gov

Applicable Catalog of Federal Domestic Assistance (CFDA) Number(s): 66.500

Eligibility Information:
See full announcement for eligibility information

Award Information:
Anticipated Type of Award: Grant
Estimated Number of Awards: Approximately four
Anticipated Funding Amount: Approximately $4 million
Potential Funding per Grant per Year: Dependent upon topic addressed by application

Sorting Code(s):
The sorting code for applications submitted in response to this solicitation is
2002-STAR-A1.

Deadline/Target Dates:
Letter of Intent Due Date(s): None
Application Proposal Due Date(s): January 18, 2002


INTRODUCTION

HUMAN HEALTH EFFECTS OF PARTICULATE MATTER

Particulate matter (PM) has been linked to a range of serious respiratory and cardiovascular health problems. The key effects associated with exposure to ambient particulate matter include: premature mortality, aggravation of respiratory and cardiovascular disease (as indicated by increased hospital admissions and emergency room visits, school absences, work loss days, and restricted activity days), aggravated asthma, acute respiratory symptoms, chronic bronchitis, decreased lung function, and increased risk of myocardial infarction.. Recent estimates indicate that exposures to PM may result in tens of thousands of excess deaths per year, and many more cases of illness among the US population.

Most epidemiologic research on ambient particulate matter has focused on acute health effects of short-term PM exposure (primarily through time-series studies). Relatively few studies on longterm ambient PM exposure have been conducted to date. These tend to show positive associations of long-term exposure with increased rates of cardiopulmonary mortality and respiratory illness. To verify and improve understanding of these findings, the National Academy of Sciences/National Research Council has recommended that EPA support additional epidemiologic studies of the effects of long-term exposures to ambient PM and gaseous copollutants (such as ozone, nitrogen oxides, and sulfur dioxide).

This RFA invites applications for the following two specific types of research on health effects of long-term exposure to ambient PM and other air pollutants: (1) retrospective epidemiologic studies that make use of currently available information on health and air quality; (2) methods/model development studies relating to future, prospective epidemiologic research.

BACKGROUND

Classifications and Source Characterization

Airborne particulate matter (PM) is not a single pollutant, but many classes of pollutants. Each class consists of several to many individual chemical species. One classification is based on the
natural division of the atmospheric aerosol into fine- and coarse-mode particles. While fine- mode particles are smaller than coarse-mode particles, they also differ in many other aspects such as formation mechanisms, chemical composition, sources, physical behavior, human exposure relationships, and control approaches required for risk reduction. Such differences alone are sufficient to justify consideration of fine- and coarse-mode particles as separate pollutants. Fine fraction particles (PM2.5), are generally defined as those particles with an aerodynamic diameter of 2.5 microns or less. The vast majority of fine particles across the US are either directly emitted from combustion sources or are formed secondarily from gaseous precursors such as sulfur dioxide, nitrogen oxides, and organic compounds. Sources of PM2.5 and precursors include combustion of coal, oil, diesel, gasoline, and wood, as well as high temperature industrial process sources such as smelters and steel mills.

Coarse fraction particles (PM10-2.5) are generally defined as those particles with an aerodynamic diameter greater than 2.5 microns, but equal to or less than 10 microns. Coarse particles are typically mechanically generated by crushing or grinding processes. Sources of coarse fraction particles include resuspended dusts and crustal material from paved or unpaved roads or from construction, farming, and mining activities.

PM10 refers to those particles that are equal to or less than 10 microns in aerodynamic diameter and therefore includes both fine- and coarse-mode fractions. Another fraction of interest to scientists is the ultrafine fraction of particles, those less than 0.1 microns.

PM Regulations and Research Priorities

In July 1997, EPA published new National Ambient Air Quality Standards (NAAQS) for PM2.5. The Agency also retained standards for PM10. The standards were set based on the numerous studies showing exposure to PM associated with increased morbidity and mortality. In establishing these standards, both EPA and the Agency's Clean Air Scientific Advisory Committee (CASAC) agreed on the importance of expanding research programs to address the key issues raised in the PM criteria and standards review.

In fiscal year (FY) 1998 Congress asked EPA to arrange for an independent study by the National Academy of Sciences, National Research Council (NRC) to develop priorities for a comprehensive PM research plan, develop a near- and long-term PM research program, and monitor research progress over the next five years. In March, 1998, the NRC released the first in a series of reports entitled Research Priorities for Airborne Particulate Matter. The NRC recommendations for PM research topics are shown below. The NRC reports can be obtained by consulting http://www.nas.edu. exit EPA


National Research Council PM Research Portfolio Recommendations*


NRC Research Topics

1. Outdoor measures versus actual human exposures
2. Exposures of susceptible subpopulations to toxic particulate-matter components
3. Characterization of emissions sources
4. Air-quality-model development and testing
5. Assessment of hazardous particulate-matter components
6. Dosimetry: deposition and fate of particles in the respiratory tract
7. Combined effects of particulate-matter and gaseous copollutants
8. Susceptible subpopulations
9. Mechanisms of injury
10. Analysis and measurement

*NRC, 1999, Research Priorities for Airborne Particulate Matter:II. Evaluating Research Progress and Updating the Portfolio


To help address a number of its priority topics, the NRC has strongly recommended that EPA support epidemiologic studies of the effects of long-term exposure to PM. The NRC recognized the difficulty of reconstructing past exposures, but maintained that identifying cohorts in which chemical-species-specific exposures can be explored was a high priority. In its most recent report, the NRC noted that greater progress was needed in supporting epidemiologic studies of the effects of long-term exposures to ambient PM that are designed to evaluate the role of other gaseous copollutants in influencing particle effects.

The NRC committee also emphasized the need for air monitoring programs that characterize actual population exposures to PM and other air pollutants, and recommended that these programs be in place before or contemporaneously with the initiation of new epidemiologic studies. To serve these goals, EPA has provided funding for State and local agencies to establish an extensive, multi-level network of ambient air monitoring sites. EPA is also working with State and local agencies to design these networks to provide maximum possible support for health effects assessment, exposure assessment, and atmospheric modeling.

The network includes approximately 1000 PM2.5 monitors to determine compliance with ambient air quality standards, and over 100 continuous monitoring sites measuring PM2.5 mass. EPA is also deploying a network of chemical speciation sites. The basic objective of the chemical speciation program is to provide data and analyses to develop seasonal and annual chemical characterizations of ambient aerosols across the nation. These chemically resolved data will be used to perform source attribution analyses, evaluate emission inventories and air quality models, and support health related research studies. Additionally, in January 2000, EPA initiated a "Super Sites" program to supplement these State and local networks. Through short-term (generally weeks or months) intensive data collection efforts, the Super Sites program uses many monitors for inter-comparisons, chemical analyses, and often includes measurements from aircraft to obtain vertical air column data.

A number of these monitoring networks are now coming on-line, and some have already begun to produce data. These data could prove useful in epidemiologic research, including research funded through this RFA. Respondents to this RFA are encouraged to make use of these data, and of data from other ambient air pollution monitoring programs, where appropriate. To support leveraging and coordination of research and monitoring efforts, a detailed description of the status and scope of PM monitoring program data collection activities may be found at http://www.epa.gov/ttn/amtic. Investigators may also contact Rich Scheffe for information (scheffe.rich@epa.gov, or 919/541-4650).

SPECIFIC AREAS OF INTEREST

Further epidemiologic studies are needed to examine the role of long-term exposure to PM and copollutants in the development of respiratory disease, cardiovascular disease, and mortality in the general population, and in potentially susceptible subpopulations such as children and the elderly. Two general approaches include: retrospective epidemiologic investigations as described in Part A below; and, prospective epidemiologic studies for which Part B seeks development of methods/models.

Applicants may submit proposals on either one or both topics (A and B) described below. For those submitting applications on both topics, two completely separate proposals are required.

A. Retrospective epidemiologic studies that make use of currently available information on health and air quality.

Previous studies on the health effects associated with long-term exposure to PM have relied largely on ambient measurements of PM10, although recent evidence indicates that PM2.5 may be of greater concern. However, very limited data are available on historical PM2.5 measurements. Thus, assessing the health effects of long-term exposure to PM2.5 in a retrospective epidemiologic study will require developing methods to estimate past exposures.


Applicants are strongly encouraged to design retrospective epidemiologic studies that rely on: 1) existing cohorts, including those that may have been established for purposes other than environmental health; and, 2) current and historic information on air pollutants. Research applications are sought which will investigate the relationship between long-term exposure to PM and adverse human health effects, including the role of PM relative to gaseous copollutants. PM2.5 is the primary focus but not the only size or chemical component of interest. Ideally, exposure and health effects analysis are needed on fine PM, ultrafine PM, and the various chemical and physical constituents of these size fractions. While evaluating the proposals against the "Review and Selection Criteria" (see section on Standard Instructions for submitting an application), the reviewers will be asked to take into account the extent to which the study:

  • Uses an existing cohort with well-characterized health endpoints that are relevant to air pollution exposures, and a sufficient number of health events to have suitable statistical power to assess pollutant-related health effects.

  • Uses an existing study cohort with sufficient individual-level information to address other risk factors, such as smoking, diet and exercise as potential confounders of pollutant-related cardiovascular effects, and addresses how these risk factors will be modeled in the analysis.

  • Includes cohort members that represent a range of exposures to airborne PM.

  • Helps increase understanding of the role of PM relative to other pollutants.

  • Includes development and application of innovative exposure assessment methods/models to estimate long-term personal or population exposures to PM2.5 from historic air pollution data and known/hypothetical relationships between PM2.5 and PM10.

  • Addresses misclassification errors for the surrogate exposures proposed.

  • Assesses the role of long-term exposures to PM size fractions, components, and PM-related copollutants on mortality, including the assessment of the potential years-of-life lost due to long-term exposure.

  • Assesses the role of long-term exposures to PM size fractions, components, and PM-related copollutants on nonfatal health endpoints, such as the development or aggravation of respiratory or cardiovascular disease.

In addition to these aspects of study design, proposals will also be evaluated on overall cost-effectiveness, including the degree to which leveraging occurs through collaboration with existing studies or use of existing data sets.

Duration: Proposals may request funding for projects with a duration of up to three years.

B. Methods development studies relating to future, prospective epidemiologic research.

Research applications are encouraged for methods development studies in support of future, prospective epidemiologic studies that would ascertain health risks of long-term exposure to ambient PM and other air pollutants. (Full-scale studies of this nature will not be funded under this RFA).

As discussed above, it is expected that new and upgraded air monitoring programs will provide a large amount of new information on ambient PM size, chemical composition, and physical properties over the next few years. This information may well prove useful in future epidemiologic studies of long-term exposure to ambient PM and other air pollutants. Research is needed to:

  • Develop methods and/or models for PM2.5, PM10-2.5, mass, PM components, and related copollutants that can be used with ambient monitoring data to provide more accurate surrogates for exposure. These methods or models will ultimately be used to improve the power of long-term epidemiological studies by taking into consideration indoor and outdoor sources of pollutants and other personal factors such as age, activity patterns, and type of housing and ventilation.

  • Develop novel, cost-effective techniques for the assessment of pulmonary and cardiovascular physiology in field studies, and demonstrate that these techniques can be well-standardized in the field across multiple, independent study centers and technicians.

Duration: Proposals may request funding for projects with a duration of up to two years.

FUNDING

It is anticipated that a total of approximately $4.0 million, including direct and indirect costs, will be awarded for topics A and B combined, depending on the availability of funds. EPA anticipates funding approximately four grants under this RFA.

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 not eligible to receive grants from EPA under this program. Federal agencies and national laboratories funded by federal agencies (Federally-funded Research and Development Centers, FFRDCs) may not apply.

Federal employees are not eligible to serve in a principal leadership role on a grant. FFRDC employees may cooperate or collaborate with eligible applicants within the limits imposed by applicable legislation and regulations. They may participate in planning, conducting, and analyzing the research directed by the principal investigator, but may not direct projects on behalf of the applicant organization or principal investigator. The principal investigator's institution may provide funds through its grant from EPA to a FFRDC for research personnel, supplies, equipment, and other expenses directly related to the research. However, salaries for permanent FFRDC employees may not be provided through this mechanism.

Federal employees may not receive salaries or in other ways augment their agency's appropriations through grants made by this program. However, federal employees may interact with grantees so long as their involvement is not essential to achieving the basic goals of the grant.1 The principal investigator's institution may also enter into an agreement with a federal agency to purchase or utilize unique supplies or services unavailable in the private sector. Examples are purchase of satellite data, census data tapes, chemical reference standards, analyses, or use of instrumentation or other facilities not available elsewhere, etc. A written justification for federal involvement must be included in the application, along with an assurance from the federal agency involved which commits it to supply the specified service.

1EPA encourages interaction between its own laboratory scientists and grant principal investigators for the sole purpose of exchanging information in research areas of common interest that may add value to their respective research activities. However, this interaction must be incidental to achieving the goals of the research under a grant. Interaction that is "incidental" is not reflected in a research proposal and involves no resource commitments.

Potential applicants who are uncertain of their eligibility should contact Jack Puzak in NCER, phone (202) 564-6825, Email: puzak.jack@epa.gov.

STANDARD INSTRUCTIONS FOR SUBMITTING AN APPLICATION
A set of special instructions on how applicants should apply for an NCER grant is found on the NCER web site, http://www.epa.gov/ncer/rfa/forms/index.html, Standard Instructions for Submitting a STAR Application. The necessary forms for submitting an application will be found on this web site.

Sorting Codes
The need for a sorting code to be used in the application and for mailing is described in the Standard Instructions for Submitting a STAR Application. The sorting code for applications submitted in response to this solicitation is 2002-STAR-A1.

The deadlines for receipt of the applications by NCER are no later than 4:00 p.m. ET, January 18, 2002.

CONTACTS
Further information, if needed, may be obtained from the EPA officials indicated below. Email inquiries are preferred.

Stacey Katz (202)564-8201
katz.stacey@epa.gov

Gail Robarge (202)564-8301
robarge.gail@epa.gov

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