Grantee Research Project Results
U.S. Environmental Protection Agency
Office of Research and Development
National Center for Environmental Research and
American Chemistry Council
Science to Achieve Results (STAR) Program
CLOSED - FOR REFERENCES PURPOSES ONLY
Environmental Statistics Research: Novel Analyses of Human Exposure Related Data
Opening Date: July 30, 2003
Closing Date: January 14, 2004
Summary of Program Requirements
Study Design Features
Standard Instructions for Submitting an Application
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Program Title: Environmental Statistics Research: Novel Analyses of Human
Exposure Related Data
Synopsis of Program:
The National Center for Environmental Research (NCER), as part of its Science to Achieve Results (STAR) Program, and the American Chemistry Council (ACC), through its Long-Range Research Initiative (LRI), signed a Memorandum of Understanding earlier this year for the purpose of developing joint Requests for Applications (RFAs) in research areas of mutual interest. The purpose of this collaboration is to engage the best scientists in the research community to promote improvements in the quantity and quality of data for use in human health and ecological risk assessment. This solicitation represents the first joint effort.
NCER and ACC are requesting applications for grants to conduct unique analyses on existing human exposure data. NCER and ACC are interested in supporting research to develop innovative statistical methods and models for application on existing exposure related data, including, but not limited to, chemical concentrations in environmental media, human behavior and activity patterns, temporal and spatial variability, and demographic information.
Applicable Catalog of Federal Domestic Assistance (CFDA) Number(s): 66.509
Institutions of higher education and not-for-profit institutions located in the U.S., and Tribal, state and local governments, are eligible to apply. See full announcement for more details.
Anticipated Type of Award: Grants (by EPA) and Contracts (by ACC).
Estimated Number of Awards: Five to ten awards.
Anticipated Funding Amount: Approximately $2 million.
Potential Funding per Grant: $50,000-150,000 per year for a duration of up to three years and no more than a total of $450,000, including direct and indirect costs. Proposals with budgets exceeding the total award limits will not be considered.
The sorting code for applications submitted in response to this solicitation is:
Letter of Intent Due Date(s): None
Application Proposal Due Date(s): January 14, 2004
Human exposure to toxic substances and the resulting health risks are a function of the numbers and concentrations of substances in the environment, their health potency, and the frequency and duration of human contact with these substances. The assessment of these exposures and risks is an inherently uncertain activity. Every step calls upon the analyst to make sense of uncertain and variable information. In addition, aggregate exposure and cumulative risk have become critical features of environmental decision-making. Aggregate exposure is defined as the sum of all exposures of a single substance occurring via all routes (e.g., air, water, food) and pathways (e.g., inhalation, ingestion and dermal contact). Cumulative exposure can be defined as the exposure resulting from the aggregate exposures to multiple substances. Both of these processes require a better understanding of the variation in the factors that contribute to exposure and risk.
Ultimately, the challenge of interpretation falls to the decision-makers for whom the assessments are performed. Because exposure assessments are relatively young applications of statistical tools and scientific principles, it is critical that methodologies be developed for addressing, quantifying, and presenting the uncertainty and variability in the models, the model inputs, and the outputs upon which the field relies. This type of research will benefit a wide range of scientists and environmental managers as they take into consideration multi-chemical, multi-pathway exposures when setting environmental standards, as mandated.
The growing concern among policy-makers and scientists that the uncertainty currently associated with risk assessments is unacceptable has lead to an increased interest in collecting better data to assess aggregate and cumulative exposures. For example, both EPA and the chemical industry are striving to reduce uncertainties associated with the risk assessments they use to make decisions concerning the safety of pesticides for both agricultural and residential use. Other programs addressing such diverse issues as air quality, leaded paint in older housing, drinking water and hazardous waste sites are also taking aggregate and cumulative exposures into consideration in their risk assessments.
In response to the needs of environmental decision-makers, research efforts have lead to a marked increase in the quality and amount of data available on human environmental exposures. Data collected during these studies usually consist of: concentrations of multiple target chemicals measured in various environmental media such as indoor and outdoor air, tap water, soil, food, house dust, and on surfaces; concentrations of chemicals in blood, urine, and other body fluids and tissue; and behavioral and demographic information collected through diaries and questionnaires.
Notable among these are the data collection efforts as part of the National Human Exposure Assessment Survey (NHEXAS). This program consisted of population-based pilot studies of the exposure of over 500 people in three areas of the United States to metals, pesticides, volatile organic compounds, and other toxic chemicals (Pellizzari, 1995; Sexton, Kleffman, and Callahan, 1995). Measurements were made of the air people breathed, the foods and beverages they consumed, and the soil and dust in and around their homes (microenvironments). The concentrations of chemicals in their blood and urine were also measured (biomarkers) and data on human behavior that can lead to exposure (human activity patterns) was gathered. Data and documentation from the NHEXAS pilot studies are available through the Human Exposure Database System (HEDS) (http://www.epa.gov/heds/index.htm).
Because human activities impact the timing, location, and degree of pollutant contact and play a key role in explaining temporal variation in human exposure, efforts to collect more detailed data on these activities have also been implemented. The National Human Activity Pattern Survey (NHAPS) and several other field-based surveys have improved the amount and quality of information available on human activities that can lead to environmental exposures. Data from these surveys are included in the EPA’s Consolidated Human Activity Database (CHAD) (http://www.epa.gov/chadnet1/).
The exposure of children has also been a high priority for environmental exposure data collection activities over the last few years. Recent studies have collected microenvironmental concentrations, human activity information and biomarker data for children aged 0-12 in several regions of the United States and Canada. These data are beginning to shed light on the unique factors that influence the exposure of this vulnerable sub-population.
Both EPA and ACC continue to conduct and support the collection of human exposure data. However, given the cost and complexity of these studies there is rarely sufficient funding available for the analysis of these data beyond that necessary to test the original study hypotheses. Therefore, they are also interested in supporting research to develop innovative statistical methods and models that will improve our understanding of human exposure and provide improved methods for assessing exposure and risk. By supporting such multi-disciplinary and innovative research, NCER and ACC believe that the science that underpins the exposure and risk assessment approaches used in environmental decision-making can be improved. Enhancing our understanding of exposures by capitalizing on these valuable existing data resources is another important step to a better understanding of the relationships between human health and the environment, and the physical and human dimensions of environmental policies.
Earlier this year, NCER and ACC signed a Memorandum of Understanding (MOU) to utilize the complementary expertise and capabilities of EPA and the ACC in the joint development of Requests for Applications (RFAs) for areas of research of mutual interest. The MOU sets forth the procedure that NCER and ACC will follow for the coordination, collaboration, and cooperative issuance of joint solicitations of research proposals (http://www.epa.gov/ncer/rfa/partners/acc). In accordance with the public procedure established in the MOU, a Federal Register Notice was issued on May 7, 2002 (67 FR 30680) that identified an interest in pursuing a joint request for applications in the area then-called “Novel Approaches for Analysis of Human Exposure Data.” Comments were solicited at the public meeting held on May 23, 2002 and the written comment period ended on June 12, 2002. This current announcement marks the issuance of the first joint solicitation.
In this solicitation, NCER and ACC are requesting applications that propose novel statistical analyses of existing chemical and behavioral data to develop new exposure information, methods, or approaches that ultimately can be used in a variety of exposure measurements, models, and/or assessments. The analyses, for example, can be used to provide estimates of various exposure concentrations and exposure factors for exposure assessments. The exposure assessments often rely on point estimates or distributions obtained from limited data sets that may not be appropriate to the populations of interest for that assessment. Further, these analyses may help determine the potential bias in estimates of national exposure factors and distributions which may result from the use of local or regional sampling. These analyses can also contribute to the development of indicators or indices that can be used to evaluate the progress or effectiveness of environmental decision-making on reducing levels of exposure. ACC and NCER are interested in funding efforts to conduct a variety of descriptive analyses on exposure-related data. Possible areas of investigation include but are not limited to:
- Novel analyses of distributions of media concentrations, exposure, and biological measurements for population subgroups by age, gender, ethnicity, socio-economic status [SES], urban versus rural, or other important groupings.
- Descriptive statistics (distributional information) for exposure related data that can be used broadly in exposure assessment, and in the design of human health effects studies.
- Analyses of method sensitivity and precision. How the censoring of data below detection limits (and alternative methods to treating these data in the analyses) affects the estimation of distributions for exposure, media concentration, and biomarker measurements, and the evaluation of associations among such measurements.
- Probabilistic methods for assessing multi-pathway exposures; methods for linking information about contaminant source, transport, and human interactions with their environment.
- Analysis of the intra-individual variability in biological, chemical and behavioral factors that contribute to exposure and determine the importance of this variability in estimating exposure.
- Methods for extrapolating small data sets to estimate population-level exposure and effects, and methods to expand the use of epidemiological data in risk assessment.
- Multi-variate statistical and model-based methods to determine relationships between concentrations in environmental media (personal air, dust, diet) and biological samples that can characterize the resultant uncertainty in estimates of environmental exposure.
- Examination populations that are highly exposed to multiple chemicals.
- Estimation or classification of exposures based on existing environmental monitoring data or models, and comparisons with direct exposure measurements.
- Methods for representing and communicating the limits and uncertainty of environmental data; approaches for characterizing and reducing uncertainty in environmental exposure and risk assessment;
- Visualization tools to assist exposure assessors in interpreting the relationships between exposure-related data sets.
- Estimates of exposure to specific environmental toxicants in the specific populations occurring via all routes and pathways.
Proposals should incorporate all of the following:
- A clear description and rationale for the selection of the study hypothesis(es) and a discussion of the appropriateness of the data sets to be used, including the population of concern, sample size and characteristics, geographic distribution, and temporal coverage;
- Demonstration that the researcher is familiar with the data sets
to be used for the proposed analyses. For example, information
should be provided on:
- The distribution of measurements (i.e., proportion of non-detects; and the ability to meet assumptions relative to the proposed statistical tests or modeling),
- Cell sized for categorical data (i.e., those used to define factors or sub-domains for the analysis or modeling),
- Treatment of the data prior to analyses – for example whether the data will be weighted; how non-detects, missing values, and data with qualifiers will be treated;
- A discussion of the data analyses that will be undertaken and the statistical and other techniques that will be used; and
- A description of the data set to be used (e.g., study design, probabilistic nature of study, QA/QC of the study and databases, and availability of meta data) whether the data sets are publicly available or a discussion of any plans for making them publicly available. Successful applicants may be required to submit quality-assured data to EPA and/or ACC in an electronic format as part of their annual reporting requirements.
Pellizzari, E (ed). 1995. Journal of Exposure Analysis and Environmental Epidemiology. Special Issue. National Human Exposure Assessment Survey (NHEXAS). 5(3): 229-444.
Sexton, K, DE Kleffman, MA Callahan. 1995. An Introduction to the National Human Exposure Assessment Survey (NHEXAS) and Related Phase I Field Studies. Journal of Exposure Analysis and Environmental Epidemiology 5(3): 229-233
It is anticipated that a total of approximately $2 million will be awarded, depending on the availability of funds. A total of approximately five to ten awards will be made under this RFA. The projected award per grant is $50,000 to $150,000 per year total costs, for up to 3 years. Requests for amounts in excess of a total of $450,000, including direct and indirect costs, will not be considered.
An award will be funded by only one of the sponsoring organizations. Awards made by EPA will be in the form of grants. Awards made by ACC will be in the form of research contracts following the principles of investigator independence (http://www.uslri.org ).
Institutions of higher education and not-for-profit institutions located in the U.S., and Tribal, state and local governments, are eligible to apply. Profit-making firms are not eligible to receive grants from EPA under this program.
National laboratories funded by federal agencies (Federally-funded Research and Development Centers, “FFRDCs”) may not apply. 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, organization, or governance 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 agencies may not apply. Federal employees are not eligible
to serve in a principal leadership role on a grant, and may not receive
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.
EPA 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.
This interaction must be incidental to achieving the goals of the research
under a grant. Interaction that is “incidental” does not involve
The principal investigator’s institution may 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. 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.
Potential applicants who are uncertain of their eligibility should contact Tom Barnwell in NCER, phone (202) 564-0824, email:firstname.lastname@example.org
All applicants, regardless of whether they specify funding from: 1) either EPA or ACC, or 2) only EPA (see Supplemental Instructions that follow), are required to use the STAR Application forms. The Standard Instructions for Submitting a STAR Application including the necessary forms will be found on the NCER web site, http://www.epa.gov/ncer/rfa/forms/.
Applicants must note in their submission, under “Research Plans,
1. Objectives” whether
they want to be considered for funding by: 1) either EPA or ACC, or 2) only
EPA. Any applicants who want to apply for funding from ACC only should contact
ACC directly for further guidance on funding opportunities separate from this
joint solicitation (http://www.uslri.org).
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: 2003-STAR-K1
The deadline for receipt of the applications by NCER is no later than 4:00 p.m. ET, January 14, 2004.
Further information, if needed, may be obtained from the EPA and ACC officials indicated below. Email inquiries are preferred.