Grantee Research Project Results
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
Clean Air Research Centers
This is the initial announcement of this funding opportunity.
Funding Opportunity Number: EPA-RC2009-STAR-C1
Catalog of Federal Domestic Assistance (CFDA) Number: 66.509
Solicitation Opening Date: June 10, 2009
Solicitation Closing Date: November 16, 2009 - extended to November 18, 2009: 11:59:59 pm Eastern Time
Eligibility Contact: William Stelz (stelz.william@epa.gov); phone: 202-343-9802
Electronic Submissions: Ron Josephson (josephson.ron@epa.gov); phone: 202-343-9643
Technical Contact: Stacey Katz (katz.stacey@epa.gov); phone: 202-343-9855
Gail Robarge (robarge.gail@epa.gov); phone: 202-343-9857
Special Announcement
- Note to all prospective applicants requiring multiple Current and Pending Support Form pages:
Due to a limitation in Adobe Acrobat's forms functionality, additional pages cannot be directly inserted into the original PDF form and preserve the form data on the subsequent pages. Multiple page form submissions can be created in Acrobat 8 and later using the "PDF Package" option in the "Create PDF from Multiple Files" function. If you have an earlier version of Adobe Standard or Professional, applicants will need to convert each PDF page of the form to an EPS (Encapsulated Post Script) file before creating the PDF for submission. The following steps will allow applicants with earlier versions of Adobe Standard or Professional to create a PDF package:
-
- Populate the first page of the PDF, and save it as a EPS (Encapsulated Post Script) file.
- Reopen the form, and populate it with the data for page 2. Save this page as a different EPS file. Repeat for as many pages as necessary.
- Use Acrobat Distiller to convert the EPS files back to PDF.
- Open Acrobat Professional, and combine the individual pages into a combined PDF file.
Access Standard STAR Forms
Research awarded under previous solicitations
SUMMARY OF PROGRAM REQUIREMENTS
Synopsis of Program:
The U.S. Environmental Protection Agency (EPA), as part of its Science to Achieve Results (STAR) program, is seeking applications for Clean Air Research Centers. EPA is interested in supporting research on the health effects of exposure to particulate matter (PM), ozone, and other air pollutants, both singly and in multipollutant atmospheres. Priority research areas include: explaining regional and temporal differences in air pollution risk; determining the origins and transformations of multipollutant atmospheres and their constituents; defining exposure/concentration-response relationships; assessing susceptibility; understanding PM effects in a multipollutant context; and developing greater understanding of PM and ozone health effects. EPA is seeking proposals for integrated, multidisciplinary research centers that will advance understanding air pollution and human health effects.
Award Information:
Anticipated Type of Award: Grant
Estimated Number of Awards: Approximately 4 awards
Anticipated Funding Amount: Approximately $32,000,000 total for all awards
Potential Funding per Award: Up to a total of $8,000,000, including direct and indirect costs, with a maximum duration of 5 years. Cost-sharing is not required. Proposals with budgets exceeding the total award limits will not be considered.
Eligibility Information:
Public nonprofit institutions/organizations (includes public institutions of higher education and hospitals) and private nonprofit institutions/organizations (includes private institutions of higher education and hospitals) located in the U.S., state and local governments, Federally Recognized Indian Tribal Governments, and U.S. territories or possessions are eligible to apply. See full announcement for more details.
Application Materials:
The necessary forms for submitting a STAR application will be found on the National Center for Environmental Research (NCER) web site, https://www.epa.gov/research-grants/funding-opportunities-how-apply-and-required-forms. Electronic submission of your application, must be performed by an authorized representative of your organization.
Applicants must submit the full application in PDF format via electronic mail to 2009-AIR-CENTERS-APPS@epa.gov with the funding opportunity number (FON) in the subject line.
If you do not have the technical capability to utilize the electronic mail submission process for this solicitation, call 1-800-490-9194 or send a webmail message to (https://www.epa.gov/research-grants/forms/contact-us-about-research-grants) at least 15 calendar days before the submission deadline to assure timely receipt of alternate submission instructions. In your message provide the funding opportunity number and title of the program, specify that you are requesting alternate submission instructions, and provide a telephone number, fax number, and an email address, if available. Alternate instructions will be e-mailed whenever possible. Any applications submitted through alternate submission methods must comply with all the provisions of this RFA, including Section IV, and be submitted by the solicitation closing date and time identified above.
Agency Contacts:
Eligibility Contact: William Stelz (stelz.william@epa.gov); phone: 202-343-9802
Electronic Submissions: Ron Josephson (josephson.ron@epa.gov); phone: 202-343-9643
Technical Contact: Stacey Katz (katz.stacey@epa.gov); phone: 202-343-9855
Gail Robarge (robarge.gail@epa.gov); phone: 202-343-9857
I. FUNDING OPPORTUNITY DESCRIPTION
A. Introduction
The Environmental Protection Agency (EPA) Office of Research and Development (ORD), National Center for Environmental Research (NCER), in cooperation with the EPA Clean Air Research Program, announces an extramural funding competition seeking applications for Clean Air Research Centers. EPA is interested in supporting research on the health effects of exposure to particulate matter (PM), ozone, and other air pollutants, both singly and in multipollutant atmospheres. Priority research areas include: explaining regional and temporal differences in air pollution risk; determining the origins and transformations of multipollutant atmospheres and their constituents; defining exposure/concentration-response relationships; assessing susceptibility; understanding PM effects in a multipollutant context; and developing greater understanding of PM and ozone health effects. EPA is seeking proposals for integrated, multidisciplinary research centers that will advance understanding of air pollution and human health effects.
B. Background
Under the Clean Air Act (CAA), EPA has the responsibility for setting air quality standards to protect the public�s health and welfare with an adequate margin of safety. For several common air pollutants, EPA establishes National Ambient Air Quality Standards (NAAQS). One of the major air pollutants of concern, particulate matter (PM), represents a broad class of chemically and physically diverse substances. For the purpose of this solicitation, PM includes thoracic coarse particles (PM10-2.5), fine particles (PM2.5) and ultrafine particles (PM0.1)1 and can be described by size, source, formation mechanism, and chemical composition. EPA�s last review of the PM NAAQS was completed in 2006. These standards include both 24-hour and annual standards for PM2.5 as well as a 24-hour standard for PM10 to provide protection of both public health and welfare. Ground-level ozone is also regulated by NAAQS; in 2008, EPA reviewed and revised the primary and secondary 8-hour ozone standards. Other pollutants regulated through the NAAQS program include NO2, SO2, carbon monoxide and lead2.
Toxic air pollutants, also known as hazardous air pollutants or air toxics, are those pollutants that are known or suspected to cause cancer or other serious health effects, such as reproductive effects or birth defects, or adverse environmental effects. The Clean Air Act requires EPA to regulate emissions of toxic air pollutants from a published list of industrial sources referred to as "source categories." EPA has developed standards for many sources of air toxics, and continues to evaluate air toxics exposures in the United States3.
Origin of the Research Centers Program
Following the promulgation of 1997 NAAQS for fine particles, Congress augmented the President�s recommended EPA budget in 1998 to address uncertainties in the evidence of PM health effects. Epidemiological studies were reporting associations between concentrations of ambient PM and adverse health outcomes including cardiopulmonary illness and premature mortality. Part of the expanded air research program included a directive to EPA to establish as many as five university-based PM research centers. In addition, EPA was directed to provide support to the National Academy of Sciences National Research Council to develop priorities for a comprehensive PM research program and review of research progress over the next five years. The recommendations in the NRC Committee�s first report, Research Priorities for Airborne Particulate Matter, I: Immediate Priorities and a Long-Range Research Portfolio (National Research Council, 1998), were used as a major source of guidance for the original PM Centers Request for Applications (RFA)4. Prospective Centers were asked to propose an integrated research program on the health effects of PM, addressing a set of research needs in the areas of exposure, dosimetry, toxicology and epidemiology.
Reducing Scientific Uncertainties in Assessment of PM Health Effects
Grants for five Centers were awarded in 19995, and the program was reviewed in 2002 by EPA�s Science Advisory Board. The SAB panel concluded that the PM Centers program was succeeding at its mid-way point and it ought to be continued with another competitive RFA (U.S. EPA Science Advisory Board 2002). The emphasis of the first PM Centers was to improve scientific understanding and reduce scientific uncertainty in the association between PM exposure and adverse health effects. The Centers made substantial progress in this area and the highest priority questions for PM shifted from whether PM could be responsible for such adverse health effects to what sources and attributes of PM (e.g., size fraction, chemical components, etc.) were primarily responsible for different health outcomes.
Linking Health Effects to PM Sources and Components
Following the issuance of the 2004 NRC report, Research Priorities for Airborne Particulate Matter, IV: Continuing Research Progress (National Research Council, 2004a), EPA held a second competition for the PM Research Centers program. As emphasized in the final NRC report, this RFA asked respondents to address the central theme of �linking health effects to PM sources and components,� and to focus on the research priorities of susceptibility, biological mechanisms, exposure-response relationships, and source linkages. From that RFA, the five current centers were funded for five years, 2005�20106.
In the fall of 2008, EPA requested a second review of the PM Research Centers program by the EPA�s Science Advisory Board. The SAB praised the successes of the PM Research Centers in reducing scientific uncertainty in atmospheric particle composition, transformation, exposure and health impacts (U.S. EPA Science Advisory Board 2009). Additionally, the panel recommended that future research centers balance a continued focus on PM and other single pollutant research with new efforts to address mixtures of air pollutants. This single pollutant research, the panel emphasized, should also be conducted in a multipollutant context.
Continuing Single Pollutant Research
Across the U.S., states and localities are struggling to deal with air pollution that exceeds allowable levels for PM and ozone. These two pollutants account for the majority of adverse heath effects due to air pollution (Bell et al. 2006, Brook et al. 2004, Jerrett et al. 2009, Pope et al. 2009, U.S. Office of Management and Budget 2009). EPA�s research program must continue to focus on understanding the linkages between sources of these pollutants, transformations in the atmosphere, actual human exposures, and resulting health impacts. While much progress has been made in recent years in linking PM components and sources to adverse health effects (Delfino et al. 2008, Lund et al. 2006, Maynard et al. 2007, McConnell et al. 2006, Peltier et al. 2008, and Peters et al. 2004), many research gaps remain. Research on PM10-2.5 and PM0.1 has increased; but evidence is limited or conflicting for connecting short-term exposures to PM in these size fractions with mortality and cardiovascular and respiratory morbidity (U.S. EPA 2008). Also, studies on long-term exposure to ultrafine and coarse PM will be challenging to do, but are of great importance for understanding cumulative health risks over time. Health outcomes such as central nervous system, reproductive and developmental effects have not been well-studied for any size fractions. In addition, research gaps related to ozone include short-term exposure and cardiovascular outcomes, effects of long-term exposure, and mortality risks. Linking health effects of PM and ozone to sources involves better understanding of primary emissions and secondary products formed in the atmosphere.
Moving Toward Multipollutant Air Research
In recent years, air pollution scientists and policy makers have recognized the potential benefits of adopting a multipollutant approach to evaluating health impacts of air pollution and management of air quality (National Research Council, 2004b). These include more realistic estimates of health risk that capture interactions among multiple pollutants and the potential for more cost effective approaches to controlling emissions. There are many elements that support moving toward a multipollutant framework for research and air quality management (Sheffe et al. 2007). These include the multipollutant nature of: 1) sources of emissions (e.g. utilities emit NOx, SO2, PM2.5); 2) controls of emissions (e.g. reduced hydrocarbon emissions from mobile sources affects PM, ozone and air toxics); 3) atmospheric processes (e.g. NOx is a precursor to both ozone and some PM2.5); 4) receptors (e.g. humans breathe in a mixture of ozone, PM, and other pollutants); and 5) effects (e.g. ozone and PM both contribute to respiratory disease).
The approach of evaluating air pollutants one-by-one does not fully capture the influence other pollutants may have on health outcomes. A single pollutant approach fails to address unmeasured or infrequently measured pollutants that could have significant health effects. There can be important health consequences from exposure to the air pollution mixture as a whole (Brook et al. 2009). For example, health effects from synergisms between ozone and other pollutants have been demonstrated in experiments involving humans and animals (Mauderly and Samet 2009). In considering how to reduce health risks, ��the total health burden of air pollution might be more effectively addressed if many pollutants were considered together by common sources, reactivity, and biological impact, rather than one-at-a-time� (Brook et al. 2009).
The NRC concluded that air quality management would be more effective if it moves from the current pollutant-by-pollutant management approach to a more integrated multipollutant strategy (NRC 2004b). Developing a multipollutant air quality management approach has multiple dimensions, including: 1) achievement of single pollutant goals recognizing multipollutant sources and atmosphere; 2) achievement of single pollutant goals recognizing co-benefits for other pollutants; 3) combinations of strategies to efficiently address multiple air quality goals; and 4) strategies to address multipollutant risks, recognizing synergies and tradeoffs in controls, air quality, and effects (Scheffe et al. 2007). However, developing multipollutant management approaches based on evaluation of multipollutant health risks is limited by the available scientific evidence on multipollutant effects on exposure and health.
Support for a multipollutant research strategy comes from the recognition that research should address the variety of ways that individual pollutants interact within a complex atmosphere and how multipollutant atmospheres may differentially impact human health effects compared to a pollutant-by-pollutant approach. The many ways that research may inform new, integrated policy approaches reflects the importance of multipollutant research.
Consideration of Social Determinants of Health
Along with the complexities of understanding the impacts of multipollutant atmospheres, is the need to understand other factors which may be affecting health outcomes. Great advances in understanding human biology and its interaction with behavior and social factors have been made in recent decades (Link and Phelan 1995, Williams 2005). Researchers have demonstrated that living in a disadvantaged neighborhood is associated with an increased incidence of coronary heart disease (CHD), even after controlling for measures of socio-economic status, e.g., personal income, education, and occupation and after adjustment for CHD risk factors including smoking, hypertension, and body mass index (Diez-Roux et al. 2001). In addition, as increasing emphasis is placed on linking health effects to air pollution sources such as traffic, research is needed to understand the role of other factors (e.g., noise, stress) in potentially affecting health outcomes.
This RFA includes a description (below) of the research needs which the Clean Air Research Center applicants will address. These needs are necessarily broad, reflecting the cross-disciplinary aspects required to characterize and understand the complex connections linking single- and multipollutant exposures with human health effects.
The specific Strategic Goal and Objective from the EPA�s Strategic Plan that relates to this solicitation are:
Goal 1: Clean Air and Global Climate Change, Objective 1.6: Enhance Science and Research
The EPA�s Strategic Plan can be found at: https://www.epa.gov/ocfo/plan/2006/entire_report.pdf (PDF) (184 pp, 11.56 MB)
1 Thoracic coarse particles (PM10-2.5), are between 2.5 and 10 microns in diameter; fine particles(PM2.5), are 2.5 microns in diameter and smaller; and ultrafine particles(PM0.1) are smaller than 0.1 microns.
2 For NAAQS information, see https://www.epa.gov/ttn/naaqs/
3 For air toxics information, see https://www.epa.gov/air/toxicair/
4 For the 1999 PM Centers RFA, see https://cfpub.epa.gov/ncer_abstracts/index.cfm/fuseaction/recipients.archive/RFATypeList/G,C99/a1pmcent.html
5 For information on the 1999-2006 PM Centers, see https://cfpub.epa.gov/ncer_abstracts/index.cfm/fuseaction/outlinks.centers/centerGroup/1
6 For information on the 2005-2010 PM Centers, see https://cfpub.epa.gov/ncer_abstracts/index.cfm/fuseaction/outlinks.centers/centerGroup/19
C. Authority and Regulations
The authority for this RFA and resulting awards is contained in the Clean Air Act, Section 103, 42 U.S.C. 7403.
For research with an international aspect, the above statutes are supplemented, as appropriate, by the National Environmental Policy Act, Section 102(2)(F).
Applicable regulations include: 40 CFR Part 30 (Uniform Administrative Requirements for Grants and Agreements with Institutions of Higher Education, Hospitals, and Other Non-Profit Organizations), 40 CFR Part 31 (Uniform Administrative Requirements for Grants and Cooperative Agreements to State and Local Governments) and 40 CFR Part 40 (Research and Demonstration Grants). Applicable OMB Circulars include: OMB Circular A-21 (Cost Principles for Educational Institutions) relocated to 2 CFR Part 220, OMB Circular A-87 (Cost Principles for State, Local and Indian Tribal Governments) relocated to 2 CFR Part 225, OMB Circular A-102 (Grants and Cooperative Agreements With State and Local Governments), OMB Circular A-110 (Uniform Administrative Requirements for Grants and Other Agreements with Institutions of Higher Education, Hospitals and Other Non-Profit Organizations) relocated to 2 CFR Part 215, and OMB Circular A-122, (Cost Principles for Non-Profit Organizations) relocated to 2 CFR Part 230.
D. Specific Research Areas of Interest/Expected Outputs and Outcomes
Research Centers
This RFA is a new competition for Clean Air Research Centers. It is open to both new Center applicants and previously-funded PM Research Centers.
The most successful applicants will take an integrated approach to their study designs. In promoting integrated multidisciplinary research, EPA is seeking applications that demonstrate the team has worked together to conceive the design of the program, to ensure each project reflects the input of different disciplines and the influence of one on another, and that the Center as a whole reflects the collective thinking of a multidisciplinary team. An application assembled from a group of representatives of several different disciplines does not guarantee that the proposed program will be integrated. In other words, it is not sufficient to have a collection of experts from different disciplines applying their individual perspectives on their own Center projects in isolation. EPA recognizes that operating with a high degree of tight scientific integration is difficult, but this is a high priority. Applicants are required: to demonstrate how the various projects contained within their proposals are integrated; to encourage participation of investigators with the recognized expertise and qualifications; and to employ cutting edge approaches. This Clean Air Research Centers funding presents the opportunity for investigators from different disciplines to work together on larger problems than could be addressed in a single grant proposal. An example of such integration might include atmospheric, health, and social scientists working together to better understand the kinds of health effects associated with exposure to multipollutant atmospheres and how these effects might vary over time and space and may also be influenced by other factors such as neighborhood stressors, demographics, etc.
EPA has made a concerted effort in recent years to foster collaboration and integrated research among health, exposure and air quality/atmospheric science disciplines. It has been a recurring theme in many recent EPA RFAs related to air pollution and is central to this RFA. Successfully integrated research will still reflect distinct research perspectives. Center applications are therefore likely to have significantly different orientations, depending on whether the overall Center design is conceived from the perspective of air quality/atmospheric science or health. EPA welcomes these different perspectives and expects that this variety of approaches is the most effective way to advance scientific understanding on how air pollution affects public health.
Applications should demonstrate strong knowledge of existing air pollution published research by providing clear explanations of how the proposal would contribute scientific advances beyond what has already been achieved to provide new insights, new approaches called for by the current state of science, or additional evidence needed to confirm or refute uncertain findings.
Multipollutant Context for Research Questions
Air pollutants originate from direct emissions from a multitude of sources as well as through atmospheric transformations of emission precursors. Consequently, air masses typically contain many pollutants present in differing amounts depending on the types of sources impacting an area and atmospheric conditions. The shift in focus to a multipollutant research program acknowledges that real-world exposures involve complex mixtures of a wide variety of air contaminants in several physical-chemical classes.
This RFA is a call for research that acknowledges the presence of several significant air pollutants in the exposures under study. For purposes of this RFA, �multipollutant� refers to a discrete set of pollutants that present significant risk to human health. Thus, research is sought that will provide a better understanding of the risks of multipollutant atmospheres that, in addition to PM, could include ozone, NO2, SO2, CO, and priority air toxics.
Any air toxics proposed for study should occur frequently with ambient PM, should be prevalent in sources of PM, such as traffic, wood or coal combustion, and should be pollutants which are expected to help explain observed PM health effects. PM itself is inherently multipollutant and consideration should be given to its size fractions and components. Applicants should provide a rationale for the set of atmospheric pollutants they choose to study.
Studies that take a multipollutant approach may be performed using either simulated or real-world atmospheres. They would likely involve estimating exposures, characterizing the interactions between and among pollutants, and understanding the health effects of a mix of air pollutants, which are either emitted directly or produced indirectly (i.e., via atmospheric processes) from various mobile, area, or point sources. In addition, other factors that may affect health outcomes such as stress and other social factors should be considered. The following examples are meant to be illustrative only. A multipollutant research project might study the health effects of near-road exposures with a focus on measuring exposure and characterizing interactions between various PM size fractions and specified air toxics. Another example might be a study that examines the impact of fresh emissions from a single source or source type (mobile, area, or point source) in urban areas that are also impacted by air masses containing aged emissions from various combustion sources (e.g., vehicles, electric generating units, etc.). A third example might be a health study of exposure to wood smoke in a valley or low-lying area subject to air inversions or other conditions that cause pollutants from wood smoke to become concentrated near the ground surface.
Applicants are expected to address at least two of the research questions 1-6 listed below. Proposals should focus on those questions in which the applicant has demonstrated expertise rather than extending beyond core strengths simply to address many topics. Applicants are encouraged to include arrangements bringing together investigators from other departments and/or institutions, provided they can demonstrate effective integration in planning research and approaches for maintaining integration throughout the implementation of research.
Research Questions
1. What are explanations for regional and temporal differences in air pollution risk?
Time-series and cohort studies of short-term and long-term exposure to PM2.5 and PM10-2.5 have reported associations with health risk that vary regionally in the U.S. This observation was highlighted by the largest U.S.-based multicity study, the Medicare Air Pollution Study (MCAPS), which reported regional heterogeneity (i.e., the largest excess risks occurred in the Northeast [1.08%]) and seasonal variation (i.e., the largest excess risks occurred during the winter season [1.49%]) in PM2.5 risk estimates (Dominici et al. 2006).
This RFA seeks applications that assess factors that vary regionally and/or temporally and that may contribute to regional heterogeneity in the observed air pollution risk. Examples of such factors include: (a) the origin (sources and secondary formation) and composition of air pollution; (b) meteorology, atmospheric processes, and topography; (c) disease incidence and mortality and (d) population characteristics (e.g., genetics, demographics, housing characteristics and other social determinants of health). Greater understanding of the reasons for observed differences in health risks could lead to insights regarding the relative importance of pollutant emission sources; the components of the air pollution mixture; transport and transformation processes of atmospheric pollutants; the effects of social factors; and the interactions between pollutants and resulting health responses.
New approaches and/or applications of existing or refined tools are required to provide higher spatio-temporal frequencies of atmospheric data on the composition and behavior of multipollutant atmospheres and their constituents to better connect them to human health. New approaches or applications may also be needed to characterize and understand how these connections might be similar or different on scales from neighborhood to urban, state, and regional. EPA encourages epidemiological studies comparing regional risks considering population characteristics and other social factors, and using novel or improved methods for addressing air pollution composition, sources, and exposure estimates. Additionally, toxicological or other approaches could be used to compare the toxicity of particles from diverse geographical locations during different seasons.
2. What are the origins (i.e., sources and secondary formation) of specific constituents of multipollutant atmospheres known or expected to be relevant to human health effects and how are those multipollutant atmospheres and constituents transported and transformed over time and space?
Understanding the origin of specific constituents of multipollutant atmospheres involves not only the source or emissions of these pollutants, but also the secondary products formed during atmospheric transport and transformation. Linking constituents to health effects may require information about constituents at a finer spatial resolution over time scales other than annual or daily averages. Because the multipollutant constituents vary in composition, concentration, (and for PM, size-fraction) and change over time, they can influence human health effects in different ways. This introduces variation and uncertainty in connecting multipollutant constituents with health effects.
To characterize this variation and reduce uncertainty in understanding the relationship between exposure to multipollutant atmospheres and health effects, more specific, sensitive, frequent, and spatially diverse measurements and numerical models are needed. However, such measurements and models must be linked to observed health effects in innovative ways. In addition, there is also a need to characterize the physical and chemical behavior and health effects of the multipollutant atmosphere as a whole, even as its constituents change over time and space. Also of keen interest is understanding how interactions among the specific constituents enhance or diminish particular health effects.
The complexity of this new research area requires collaboration among atmospheric, air quality, exposure and health scientists to design studies that are thoughtfully integrated and test the most relevant and important hypotheses about effects from multipollutant atmospheres and their components.
3. What subpopulations are at increased risk of adverse health outcomes from exposure to PM (components, size fractions) and/or air pollutant mixtures, and why are they susceptible?
Understanding who is more susceptible to the adverse health effects of exposure to PM (or air pollution more broadly) is important for the design of programs to reduce public health risks. Susceptibility refers to the biological characteristics of an individual, which can include life stage, genetics, and pre-existing disease. Vulnerability refers to non-biological variables (such as socioeconomic status or cultural practices) associated with an individual that can result in a health effect.
Research is needed to improve understanding of who is susceptible and why, including whether exposure to PM/air pollutants results in: 1) susceptibility to more rapid disease progression of an existing illness, 2) greater likelihood of adverse effects from other environmental exposures (e.g., more susceptible to allergens because of air pollution exposure), or 3) adverse impacts on individuals who are vulnerable due to other factors. Also of interest is whether early life exposures affect susceptibility to other health effects later in life. Studies of susceptibility are strongest when supported by evidence of biological mechanisms. Understanding why a group is susceptible provides insights into the biological activity of the air pollutant.
To address the questions of susceptibility, proposals may employ any number of approaches including in vitro, animal, controlled human exposure, panel studies, small clinical studies, and epidemiologic studies. Also encouraged are novel applications of appropriate animal models, including naturally susceptible, disease-induced, and genetically or pharmacologically manipulated models.
4. What are the shapes of the exposure/concentration-response relationships for PM and/or ozone and specific health outcomes? What are the lowest PM or ozone concentrations that are associated with adverse health effects?
Understanding concentration-response relationships is important to characterize the public health impact of exposure to PM and/or ozone. Ozone and PM pollution remain exceedingly difficult to control in many areas of the country after more than 30 years of active research and management.
Determining the shapes of the concentration-response relationships of ozone, PM2.5, and PM10-2.5 is important for interpreting the relevance of the high-concentration exposures used in toxicological studies to the lower-concentration ambient exposures encountered by humans in daily life, and for understanding any differences in effects from human exposures at different ambient concentrations. Uncertainty exists about concentration-response functions and various health outcomes. Response functions for pollutant exposures in susceptible and vulnerable groups have not been well characterized for PM or ozone. Further studies are needed to fully characterize the low end of concentration-response functions, including the presence or absence of thresholds, for a variety of PM or ozone health effects.
To best characterize the concentration-response functions for ozone and PM at ambient levels, this research question calls for epidemiological, human clinical, or toxicological studies informed by air quality and atmospheric science.
5. How can the health effects of PM (its components/size fractions and sources) be better understood in a multipollutant context? How would findings on single pollutants be compared to findings of single pollutants studied in the context of a multipollutant atmosphere?
In any specific exposure context (for example, neighborhoods near a busy road or communities located downwind of a major urban industrial corridor) a population is simultaneously exposed to particles, gases, and hazardous air pollutants that separately and together have an effect on health status. In addition, the components in any particular atmosphere can interact with each other and be transformed by a number of local and regional factors.
This is a call for research that acknowledges the presence of several significant air pollutants in the exposures under study. Research is sought that will provide a better understanding of the risks of PM (its components/size fractions and sources) in multipollutant atmospheres that are reasonably expected to present significant risks to human health. Any air toxics proposed for study should be ones which frequently occur together with ambient PM, are prevalent in sources of PM like traffic or other combustion, and should be pollutants which may be expected to help explain observed health effects of air pollution. Studies should be tightly integrated among health, exposure, and air quality/atmospheric science, and applicants should provide a rationale for the set of atmospheric pollutants they choose to study.
6. How can effects linked with exposure to either PM or ozone be better understood? What are the biologic mechanisms underlying observed health effects?
This question addresses the need to develop an improved understanding of the health effects of PM and ozone. Research has found greater rates of PM-associated mortality and hospitalization in persons with pre-existing cardiovascular or pulmonary disease, but it is not yet clear whether and how exposure to PM and/or ozone contributes to the exacerbation and acceleration of disease Additionally, while there is considerable evidence for cardiovascular and pulmonary health outcomes associated with PM, much less is known about whether PM exposure plays a role in other effects. Recent epidemiological studies have linked ozone exposure to premature mortality, yet more supporting evidence is needed.
Research is needed to determine whether and how exposure to PM and/or ozone leads to worsening of disease in persons with pre-existing cardiovascular or pulmonary disease. Additionally, more evidence is needed to understand the role of exposure to PM and/or ozone in occurrence of less well studied health effects, such as neurological, reproductive or developmental effects. For PM, the weight of evidence for certain health outcomes varies for PM2.5, PM10-2.5, and PM0.1 as well as for components, and possible interactions with copollutant gases. Underlying biological mechanisms are important in contributing to the weight of evidence and are still not understood for many of these health outcomes and attributes of PM individually or in combination. For ozone, the effects on the respiratory system have been researched fairly extensively, but the weight of evidence for other health endpoints and outcomes associated with ozone exposure is limited.
To address the questions of PM and ozone health effects that are not well understood, proposals may employ any number of approaches including in vitro, animal, controlled human exposure, panel, small clinical and epidemiologic studies. Also encouraged are novel application of appropriate animal models, including naturally susceptible, disease-induced, and genetically or pharmacologically manipulated models.
Expected Outputs and Outcomes
Note to applicant: The term �output� means an environmental activity or effort, and associated work products, related to a specific environmental goal(s), (e.g., testing a new methodology), that will be produced or developed over a period of time under the agreement. The term �outcome� means the result, effect, or consequence that will occur from the above activit(ies) that is related to an environmental, behavioral, or health-related objective.
The expected outputs from this research will be scientific data and information on the human health effects of exposures to air pollutants. These outputs are expected to include articles in peer-reviewed journals, websites, periodic reports, and presentations at scientific conferences. The desired outcomes of this effort include: increased understanding of how multiple influences, including sources, atmospheric transport and transformation, exposure concentrations, and social and other factors affect health outcomes from exposure to air pollution. Additionally, the use of this information will reduce the uncertainty in health risk assessments of air pollutants and increase the efficiency and effectiveness of state/local air quality management strategies.
E. References
Bell, M.L., R.D. Peng, and F. Dominici. The exposure-response curve for ozone and risk of mortality and the adequacy of current ozone regulations, Environmental Health Perspectives 114: 532-536 (2006).
Brook, J.R., K.L. Demerjian, G. Hidy, L.T. Molina, W.T. Pennel, and R. Scheffe. New Directions: Results-Oriented Multi-Pollutant Air Quality Management, Atmospheric Environment (2009). doi: 10.1016/j.atmosenv.2008.12.041
Brook, R.D, B. Franklin, W. Cascio, Y. Hong, G. Howard, M. Lipsett, R. Luepker, M. Mittleman, J. Samet, S.C. Smith, and I. Tager. Air Pollution and Cardiovascular Disease: A Statement for Healthcare Professionals from the Expert Panel on Population and Prevention Science of the American Heart Association. Circulation 109:2655-2671 (2004).
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F. Special Requirements
Agency policy prevents EPA technical staff and managers from providing individual applicants with information that may create an unfair competitive advantage. Consequently, EPA employees will not review, comment, advise, and/or provide technical assistance to applicants preparing applications in response to EPA RFAs, nor will they endorse an application or discuss in any manner how the Agency will apply the published evaluation criteria for this competition.
Multiple Investigator applications may be submitted as: (1) a single Lead Principal Investigator (PI) application with Co-PI(s) or (2) a Multiple PI application (with a single Contact PI). If you choose to submit a Multiple PI application, you must follow the specific instructions provided in Sections IV. and V. of this RFA. For further information, please see the EPA Implementation Plan for Policy on Multiple Principal Investigators (http://rbm.nih.gov/toolkit.htm).
Groups of two or more eligible applicants may choose to form a consortium and submit a single application for this assistance agreement. The application must identify which organization will be the recipient of the assistance agreement and which organizations(s) will be subawardees of the recipient.
The application must include a plan (see �Data Plan� in section IV.B.5.c.) to make available to the public all data generated from observations, analyses, or model development (primary data) and any secondary (or existing) data used under an agreement awarded from this RFA. The data must be available in a format and with documentation such that they may be used by others in the scientific community.
These awards may involve the collection of �Geospatial Information,� which includes information that identifies the geographic location and characteristics of natural or constructed features or boundaries on the Earth or applications, tools, and hardware associated with the generation, maintenance, or distribution of such information. This information may be derived from, among other things, a Geographic Positioning System (GPS), remote sensing, mapping, charting, and surveying technologies, or statistical data.
Each application must address the following (for content and form of application submission and page limitations, see Section IV.B):
1. Center Description (5 page limit): Applications must describe the overall goals, objectives, and approach for the Center, including how the Center will pursue a multidisciplinary and thematic approach to the problems to be investigated.
2. Project Descriptions (15 page limit for each project description): Applications must describe one or more projects that address at least two of the research questions described above in Section D. Each of the specific individual research projects should be completely described according to the instructions in Section IV below. Individual project descriptions must explain how the project fits into the overall Center program and relates to other projects in the proposal.
3. Administrative Core Unit (15 page limit): Each Center shall have an Administrative Core Unit which provides overall oversight, coordination and integration of the Center�s activities. As part of the Administrative Core description, applications must provide a Center Integration Plan describing how the program will be integrated internally. Center proposals should take a multidisciplinary approach. The Center�s Integration Plan, at minimum, should indicate how programmatic and funding decisions will be made; how project objectives will be successfully achieved in a timely manner; how investigators from different disciplines within the Center will communicate on a regular basis about the development and progress of Center projects; how progress toward achieving the expected results (outputs and outcomes) will be monitored and measured; who will set priorities, and who will be responsible for implementing the integration plan, assuring compliance with the plan, and evaluating its effectiveness in achieving integration within the Center.
The Center proposal should also address how the Center will disseminate research findings and other information. Publishing research results in scientific journals is essential, however, it is not sufficient. Plans for Center websites and other means of communicating results should be described.
Additional responsibilities of the Administrative Core include (as described below under �After Grant Award�): coordination and integration among Centers, organization of Scientific Advisory Committee (SAC) meetings and development of responses to SAC recommendations. The SAC will be responsible for providing objective, independent, technical advice to the Center to ensure scientific quality and progress.
4. If appropriate and desired, a Center may elect to have one or more Facility Support Cores that provide a technique, service, or instrumentation that will enhance ongoing research efforts across the Center�s specific projects. Examples of such facilities are analytical chemistry laboratories, statistics centers, laboratory animal facilities, etc. The application must provide a compelling rationale for why such a core is needed and how it will be used by multiple projects within the proposed center (15 page limit per Core).
5. In conducting its research, the Center must demonstrate a willingness to use, as appropriate, existing or future air quality databases, especially relating to PM, as they become available. In addition, the Centers are encouraged to seek out and participate collaboratively with ongoing/planned intensive air quality monitoring efforts.
After Grant Award
1. Integration Among Centers - According to EPA�s 2002 Science Advisory Board in its review of the PM Centers program, �There is a clear need for and benefit from increased inter-Center interaction...The Centers program should stimulate and facilitate collaboration within and between the five Centers, with the goal of harmonizing designs, methods of measurement, and analysis...� Experience with the PM centers underscored the notion that integration among the Centers enhanced scientific understanding and research productivity. Integration among Centers requires significant commitment, time and effort.
Within three months of the award, the Clean Air Research Centers will form a Coordination Committee that will consult monthly to exchange ideas, research needs, protocols, and other information. The group will identify research areas that would benefit from harmonization, joint workshops, sharing of data, samples, expertise or technologies. EPA anticipates that the Coordination Committee will discuss and act on some areas of shared interest, and that subcommittees will be formed as needed to address more specialized topics. EPA scientists will participate in joint working groups as appropriate. To support these activities, Centers will participate in annual Centers meetings to review research progress and in workshops on specific research topics. The Administrative Core must allocate sufficient funding to: 1) host one joint Centers workshop; 2) host one and participate in four annual Centers meetings (6-10 Center attendees per meeting) to review research progress; 3) participate in six workshops over the five year project period (approximately 3 Center attendees per workshop); and 4) support approximately $50,000 annually in comparative or collaborative studies.
2. Communications - Centers are expected to develop and maintain Center web sites, communicate key findings at annual scientific conferences, and participate in annual EPA investigators meetings. The Centers will each produce annual progress reports and a final report at the end of the grant period. Throughout the five year period, project summaries and final results will be provided in a format compatible with broader efforts to compile and synthesize the large amounts of information on air pollutants. In addition, the Centers are expected to cooperate in the production of an integrated, interim report of progress midway through the grant cycle and a final report of findings at the conclusion of the grant.
3. Administrative Contact - Each Center will identify an individual to be the main point of administrative contact with the EPA Project Officers. This person will be responsible for ensuring that information on human subjects, animal welfare, Center publications, press releases, progress reports, quality assurance, Science Advisory Committees and other documentation is provided to the Project Officer in a timely fashion.
4. Science Advisory Committees - After award, each Center must establish a SAC. The SAC membership will typically consist of nine to twelve peers selected from the academic, private and public sectors and an EPA representative(s). The function of the SAC is to assist in evaluating the (1) merit, value and contribution of existing and future research projects, and (2) relevance and importance of the individual research elements to accomplishing the overall goals of the Center. Within 90 days of the award, the Principal Investigator must submit a list of nominees for the SAC to the Project Officer. Potential SAC members must NOT be contacted, identified, or queried prior to receipt of the award.
Each Center will hold a meeting with its SAC annually. Upon receiving the written recommendations from the SAC, the Center director shall submit a formal letter to EPA and the SAC chair with its response to the SAC comments and a plan for how the Center will implement improvements.
It is anticipated that a total of approximately $32,000,000 will be awarded under this announcement, depending on the availability of funds and quality of applications received. The EPA anticipates funding approximately 4 awards under this RFA. Requests for amounts in excess of a total of $8,000,000, including direct and indirect costs, will not be considered. The total project period requested in an application submitted for this RFA may not exceed 5 years. The EPA reserves the right to reject all applications and make no awards, or make fewer awards than anticipated, under this RFA. The EPA reserves the right to make additional awards under this announcement, consistent with Agency policy, if additional funding becomes available after the original selections are made. Any additional selection
The perspectives, information and conclusions conveyed in research project abstracts, progress reports, final reports, journal abstracts and journal publications convey the viewpoints of the principal investigator and may not represent the views and policies of ORD and EPA. Conclusions drawn by the principal investigators have not been reviewed by the Agency.